Director, Quality Control Resume Sample
Madie Bernhard
1735 Viola Rapid,
Boston,
MA
+1 (555) 183 7280
Work Experience
Director, Quality Control
04/2017
-
PRESENT
Chicago, IL
- Clear understanding of Quality Control equipment validation and maintenance, as well as data integrity requirements
- Experience interfacing with regulatory agencies and participating in regulatory authority inspections
- Establish department’s short and long term goals in support of company goals, including defining personnel needs, contract lab requirements, lab supplies, capital requirements
- Keen awareness of maintaining strong communications with stakeholders including providing regular updates and providing timely communications regarding resource concerns and prompt notice of issues
- Represent department in project teams, to provide quality input across functional areas, to maintain close communication and interaction with other functional groups and managers, and to provide quality reports and metrics to senior management
- Passion for continual improvement with ability to develop and improve workflows and procedures within the Quality Control Group
- Proven track record of effective leadership in hiring, training and developing staff
- Knowledge of environmental monitoring, microbial and raw material testing, and cleaning verification would be advantageous
Associate Director, Quality Control
06/2011
-
02/2017
Phoenix, AZ
- Ensures and is ultimately responsible for compliance of laboratory operations with established SOPs, FDA regulations as well as compendial requirements
- Ensures thorough investigations are performed leading to the assignment of root causes and the implementation of effective corrective/preventive actions (CAPA) to minimize the possibility of recurrence
- Supports analytical submissions as well as Pre-Approval inspection support. Direct the technical staff of Quality Control and all documentations, which support CMC regulatory submission
- Participates in regulatory agency inspections as required
- Develops and mentors direct and indirect reports
- Directs the generation and implementation of performance and training programs for Quality Control personnel
- Ensures that departmental performance adheres to established performance metrics. Ensures departmental tasks are completed by their established target dates
- Responsible for the assignment of the laboratory disposition of test samples
Director Quality Control
03/2008
-
05/2011
Chicago, IL
- Interfaces with R&D and provides feedback on analytical test method development and validation efforts
- Embraces the concept of Continuous Improvement to optimize laboratory performance
- Maintains laboratory operating costs within established budgets
- Implement and revise SOPs as deemed necessary
- Responsible for Raw Material, Finished Products and Stability Departments
- Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals
- Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures
- Direct QC Staff in the timely completion of testing (e.g. DS, DP and FINP release, raw materials, in process samples, utilities, direct materials, medical devices, environmental monitoring, process and cleaning validation.)
- Provide QC staff with technical guidance on test methods and relevant procedures
Education
Shawnee State University
2002 - 2007
Engineer's Degree in Chemistry
Professional Skills
- Strong leadership skills with excellent coaching and people management skills
- Strong leadership skills, with experience managing large teams
- Strong analytical and balanced decision making skills
- Computer “literate”; basic trouble shooting skills
- Understand role's impact and influencing skills
- Vaccine manufacturing experience and/or Quality Systems experience
- Prioritization and Planning: The ability to manage multiple initiatives simultaneously, working with a cross-section of colleagues and third-party resources
How to write Director, Quality Control Resume
Director, Quality Control role is responsible for leadership, analytical, compensation, credit, training, database, auditing, reporting, manufacturing, design.
To write great resume for director, quality control job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Quality Control Resume
The section contact information is important in your director, quality control resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, Quality Control Resume
The section work experience is an essential part of your director, quality control resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, quality control responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, quality control position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Quality Control resume experience can include:
- Demonstrated capability of interpreting and trending data and communicating and presenting results to peers and management
- Ensures test equipment and process validations are completed in a timely manner
- Ensures that departmental procedures are effective and compliant
- Support assay development and validation by designing experiments
- Provides direct supervision to professional individual contributors and/or skilled, support individual contributors
- Working knowledge of relational database systems
Education on a Director, Quality Control Resume
Make sure to make education a priority on your director, quality control resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, quality control experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, Quality Control Resume
When listing skills on your director, quality control resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, quality control skills:
- Excellent managerial skills as well as problem solving skills. Handle issues appropriately and with a sense of urgency
- Excellent communication skills: Ensuring timely issue escalation to Quality senior management and cross-functional support teams
- Good analytical skill and able to deal with problem analysis, resolution and follow up preventive action with manufacturers
- Effectively negotiate and build collaboration amongst individuals
- Effectively communicate vision for department
- Using statistically based methods help to design data treatment methods, assay validity and acceptance criterion for bioassays and other product release assays
List of Typical Experience For a Director, Quality Control Resume
1
Experience For Associate Director, Quality Control Resume
- Demonstrated written and verbal communication skills with peers and management
- Possess excellent supervisory and interpersonal skills and be able to communicate with all level personnel and regulatory authorities
- Possess strong leadership, project and people management skills. Ability to develop, mentor and manage a large team of employees
- Experience with troubleshooting, optimizing, transferring, and qualifying/validating analytical methods per US FDA and ICH guidelines
- Writing Standard Operating Procedures (SOP’s), test methods, and qualification/validation reports
- Broad experience in managing the multiple sourcing locations
- Hands-on experience with various Analytical Instruments, includes, but is not limited to the following: HPLC, GC, IR, UV, Dissolution, etc
2
Experience For Senior Director, Quality Control Resume
- Characterization/optimization/validation of cell-based potency assays, binding assays
- The ability to manage personnel at multiple sites with differing priorities is important
- Collect, verify and validate the quality callouts from Store Operations and Internal Markets providing consistent feedback to overall organization
- Identifies and addresses technical and validation gaps in analytical methods and implement improvements in analytical methods per ICH requirements
- Ensure investigations are conducted in a timely manner with thorough Root Cause Analysis and effective CAPAs
- Serve as an SME for analytical methodologies, specifications, stability studies, and reference standards for project teams and employee skill development
- Develops compliance strategy and generates and reviews method qualification and validation protocols and reports
3
Experience For Director Quality Control Resume
- Solid understanding of cGMPs, GLPs, and regulations
- Previous experience managing others in a bioanalytical laboratory
- Strong business acumen of Assurant’s overall diverse product portfolio, customer base, systems requirements and business capabilities
- Evolving knowledge of global organization and industry trends
- Establishing stability program strategy and oversight of commercial annual commitments and enrollments
- Cultivating positive relationships and collaboration with Quality teams abroad, Internal Markets and suppliers
- Ensure timely generation and reporting of test results in support of manufacturing operations (e.g., hold testing)
- Ensure support of manufacturing operations through troubleshooting, transfer activities and other product lifecycle testing
4
Experience For Associate Director Quality Control Resume
- Liaise with regulatory agencies and external sources regarding issues affecting product quality as QC SME
- Manage and develop direct reports by setting clear expectations, as well as resolving conflicts
- Collaborate with senior manufacturing management to develop strategic planning direction
- Aligns resources with business unit needs to ensure on time execution and release of testing results (meeting customer and regulatory expectations)
- Ensure data is generated, documented and reported following cGMP procedures
5
Experience For Director, Quality Control Management Resume
- Direct QC Staff in the timely resolution of issues, including discrepancies, investigations, and implementation of CAPA (corrective actions preventive actions)
- Global QC, Other site QC leaders, ATC/ATL, Manufacturing, Local MSAT
- General basic accounting knowledge
- Provide work planning and operational guidance to lab personnel and technical review
- Provide information to investigators as needed during regulatory audits
6
Experience For Senior Director Quality Control Resume
- Business continuity and long-term planning
- Documents work according to SOP's and compliance requirements
- Revises and updates standard operating procedures as needed
- Provide guidance and input on internal and external quality systems including temperature excursions (clinical and commercial),
- Lead diverse Reagent Test areas across multiple shifts. Staff and train department to meet clinical manufacturing standards
- Manage assigned operations budget, completing all goals in a timely manner
- Responsible for guidance on creation, changing and issuance of lab related documents
7
Experience For Risk Director Quality Control Resume
- Develops and manages operating budget for lab/ teams
- Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence
- Ensure calibration and maintenance of laboratory equipment and systems
- Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness
- Ensure system, computer, change control, and analytical data is reviewed, evaluated and approved against established criteria
8
Experience For Director Quality Control Analytical Chemistry Resume
- Direct the review and approval of all applicable Quality Control documents and ensure documents are updated
- Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods
- Lead Analytical transfers and local analytical method verifications as required by sites
- Escalate any potential quality issues revealed during QC testing or processing of products (e.g., QRB), especially quality or regulatory issues with the potential to affect product quality or regulatory compliance
- Support regulatory inspections and partner audits, approvals of protocols and reports of third party QC laboratories
- Personnel management both full service and contract employees
- Manages departmental spend in accordance with budget
9
Experience For Executive Director Quality Control Resume
- Delivers on continuous improvement and productivity commitments
- Supervisory and managerial experiences with demonstrated leadership capability in laboratory environment with people development and performance management skills
- Network and liaise as appropriate with other Quality professionals to ensure ongoing knowledge of evolving Quality Laboratory standards
- Lead the design and implementation of training programs for internal staff members
- Provide guidance and coaching to intradepartmental staff members
10
Experience For Director Quality Control Quality Assurance Resume
- Ensure all QC Standards, Procedures and other GMP documentation are implemented and continuously maintained in a compliant and inspection ready manner
- Drive the implementation of new QC lab systems and ensure all QC lab systems supporting the QC operation are continuously maintained in a compliant and inspection ready manner
- Ensure that agreed QC testing lead times are implemented and adhered to for associated in-process, release and stability testing
- Ensure all QC data required for APRs/complex investigations is supported and provided within agreed timeframes
- Ensure standardized QC practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools
- Drive the implementation of new QC test technologies
- Participate in QC forums integral to the development of an Alexion QC network
List of Typical Skills For a Director, Quality Control Resume
1
Skills For Associate Director, Quality Control Resume
- Proven and broad knowledge of chemical analytical techniques and excellent critical listening skills
- Excellent communication and written skills to successfully partner with internal collaborators and external vendors
- Proven experience in the biologics realm is required
- Previous experience managing and leading others in a bioanalytical laboratory
- Experience in establishing and improving quality systems is highly desirable
- Pharmaceutical industry experience in Quality, Manufacturing, Engineering or Process Development
- Strong GMP background including working knowledge of GLP/GMP
- Interface with Analytical Process Technology/Manufacturing Technology to ensure assays are validated to current GMP standards
2
Skills For Senior Director, Quality Control Resume
- Responsible for the process of evaluating new technology for the lab and subsequent validation
- Product/the international third party lab/manufacturing experience would be advantageous
- Oversees laboratory computer and network support including security, maintenance, automation, validation, qualification and system upgrade activities
- Proven ability to build, mentor and grow agile high performing teams
- Extensive experience of the all regulatory requirements associated with QC method submissions/variations etc, BLA writing and submission
- Collaboration and Teamwork: Proven track record of teamwork, innovation and results
3
Skills For Director Quality Control Resume
- Manage and improve operating mechanisms to ensure that non-conformances (OOLs, OOSs, and CAPAs) are completed in an effective and timely manner
- Experience with QC release and stability testing for licensed biopharmaceuticals products is required
- Extensive experience in liaison with review and inspection divisions of health authorities e.g.; FDA, EMA and PMDA
- Experience in apparel and footwear industry
- Five years’ experience in a 14 CFR 145 Repair Station
- Proven ability to work in a matrixed organization
4
Skills For Associate Director Quality Control Resume
- Or combination of MS with 12 years, PhD with 10 years) of experience in pharmaceutical QC operations for development through commercial products
- Passing inspections and bringing the lab to the next level, e.g. improving on IT automation and data integrity
- Working together with other Lab Managers in the MSD network
- Providing summaries of test results to appropriate personnel as needed
- Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving QC Testing and Stability Studies
- Responsible for assay troubleshooting, trending and supporting complex investigations
5
Skills For Director, Quality Control Management Resume
- Knowledge and understanding of apparel and/or footwear quality regulation including testing
- Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning
- Strategic Business Perspective: Strategic thinking, judgment and sound decision-making are key, with the ability to think and act under pressure
- Manage the Quality staff in the USA and the refurbishing centers, providing guidance, technical advice and solutions to resolve quality issues
- Assist in identifying and qualifying new raw materials and suppliers
- Familiarity with pharmaceutical manufacturing and packaging equipment is necessary
- Prepare and host regulatory inspections for QC and address analytical issues during inspections and regulatory filing
- Performs personnel management functions including coaching, personnel development, and performance evaluations
6
Skills For Senior Director Quality Control Resume
- Assist in investigations into atypical test results obtained during product testing
- Stays current in the state of the art by attending and presenting at relevant industry conferences and workgroups
- Provide technical expertise for personnel training, deviations, CAPA, inventory management, cGMP compliance, data trending
- As a leader within Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision making
- Oversee budget and resource allocation, deriving value from laboratory activities while maintaining alignment with site and corporate strategic objectives
- Intermediate understanding of MS Office 2010
- Analytical testing, laboratory investigations, deviation management, protocol and report development and review
- Results Orientation: Be able to make complex things simple while supporting decisions with appropriate data
7
Skills For Risk Director Quality Control Resume
- Execution: Comfort balancing strategic and tactical requirements in lean environment
- Meet Laboratory department goals and metrics including adherence to financial budget
- Manage complex projects, resolve complex issues, critical problem solving
- Knowledge of IVD Manufacturing processes and technology
- Basic knowledge of testing equipment operations
- Work with Sales and Marketing to facilitate education programs and support Voice of the Consumer or Customer initiatives
- Develop scope of work and proposal for new and existing clients
- Present regular status updates upward on the Quality Control group’s recent accomplishments, upcoming milestones and risks/dependencies
- An in-depth knowledge of chemistry, pharmaceutical analytical technologies, including microbiology and government regulations is required
8
Skills For Director Quality Control Analytical Chemistry Resume
- A working knowledge of statistics and computerization (electronic documentation) of QA data is required
- Creates monthly testing reports
- Advise Manufacturing, QA, RA, Facilities and Material Management of Lab support requirements and issues associated with service provided
- Provides key leadership, vision and direction to the QC Lab Support group while providing operational and technical expertise
- Represents the department during high-level discussions and investigations with external customers, vendors and FDA representatives
- Author, review, and approve Standard Operating Procedures
- Serve as the Subject Matter Expert for all release testing related matters
9
Skills For Executive Director Quality Control Resume
- Responsible for establishment and maintenance of the Environmental Monitoring program in accordance with regulatory and internal Merck guidance
- Manage trending program for Utility Systems and Classified Areas
- Provide Leadership and direction to Quality Control (QC) staff to ensure QC tests and procedures are aligned with CFRs and regulatory, global and internal guidelines
- Ensures testing and release services are provided to Production and R&D in support of established schedules
- Establishes departmental objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement
10
Skills For Director Quality Control Quality Assurance Resume
- Laboratory liaison from/to Industrial Operations
- Provide Analytical Chemistry group long term objectives, general policies and management guidance based on business directions and goals
- Provide Quality Laboratory management guidance to policies based on business directions and goals
- Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation
- Ensure compliance with testing procedures, specifications and company policies. Prepare the department for both internal and external authorities. Serve as a Quality representative for the lab and interface with investigators and customers
- Work closely with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support. Responsible for leading and / or supporting complex investigations and trending laboratory results
List of Typical Responsibilities For a Director, Quality Control Resume
1
Responsibilities For Associate Director, Quality Control Resume
- Collaborate with cross-functional project teams to support QC activities necessary for the management of 3rd party CMO’s, as well as timing and strategies for method validation and method transfers
- A demonstrated ability to communicate effectively with people at all levels in the organization, from other departments and divisions, as well as regulatory agencies is required
- Proven process optimization experience utilizing DoE
- Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations
- Strong working knowledge of cGMPs and regulatory expectations related to QC roles and responsibilities
- Manage budget of CMA samples and testing fee
- Communicate the quality issues found with BU, sourcing, 3 divisional quality function, advanced creation etc
2
Responsibilities For Senior Director, Quality Control Resume
- Represent Reagent Test in Sales and Operations Planning cycles and with the New Product Introduction pipeline
- Review release/stability data and generate COA’s
- Ensure data is reviewed in a timely manner for release, stability and/or regulatory submissions
- Trend Release and Stability data (graphical analysis) and Statistical Analysis where applicable
- Ensure all applicable excursions, change controls are properly documented and closed on time
- As a senior Quality representative for the company responsibilities include being the primary interface with business and system related issues at contract manufacturing and laboratory organizations (CMO’s)
- Aligns goals and metrics of the department with the Company’s goals, policies and strategies
- Maintains the facility’s corrective and preventative action system (APRISe) and ensures timely reporting, verification, and closeout of issues, including root cause analysis
- QA/QC Designee for US sites in the Corporate CQMS System (i.e., Trackwise) for all applicable Quality interactions (Deviations, Investigations, CAPA’s, etc.)
3
Responsibilities For Director Quality Control Resume
- Proficient in all Microsoft applications and various specialized software applications
- Technical Review and Writing (includes but is not limited to the following: Protocols, Test Methods, Standard Operating Procedures, Corporate Policies, Global Quality Standards, Quality Agreements, Confidentiality Disclosure Agreements, Change Controls, Deviations, Investigations, CAPA’s responses to Regulatory Agency observations, etc.)
- Auditor/Inspector (Data and Document Review, Internal and External Inspection, etc.)
- Ensures corporate compliance to Regulatory Agency requirements (i.e. FDA, EU, DEA, etc.)
- Oversee QC biochemistry testing operation to support product release, stability testing and in-process control, product investigation and assay validation under cGMP
- Data analysis and review and release of product
4
Responsibilities For Associate Director Quality Control Resume
- Manage assay transfer internally from R&D to the QC laboratory
- Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed
- Author technical and regulatory reports, SOPs, TCRs, CAPAs and MCs
- Perform investigations for OOS deviations
- Ensure quality and regulatory compliance
- Prepares annual employee performance evaluations and recommendations
- Work with members of Manufacturing, QA, RA and R/D to provide quality control guidance and technical support for product release, stability shelf-life determination, process validation, regulatory filing and side-wide compliance
5
Responsibilities For Director, Quality Control Management Resume
- Communicate and lead with transparency
- Lead department for optimal performance and set course for future
- Accountable for performance and results of department
- Influence outside of own department
- Create departmental goals and assign resources based on business needs
- Diagnose status of organization and positively impact culture
6
Responsibilities For Senior Director Quality Control Resume
- Work with relevant SMEs from IOPS and Tarrytown as well as laboratory management to determine best practices for bioassay and binding assay design and execution
- Receive research assays from R&D for clinical candidates and optimize them for QC. Oversee qualification of these assays for Phase I
- Serve as analytical lead on the CMC development team for multiple clinical programs
- Review/approve test results and write/approve technical reports
- Represents analytical sciences at meetings to keep informed of manufacturing and clinical development needs and priorities, and provide analytical information and expertise
- Trains junior staff and direct laboratory work to show proof of concept for new ideas
- Ensures lab compliance with applicable cGMP regulations and SOPs
- Continuously drive to improve processes
- BS in the Sciences
7
Responsibilities For Risk Director Quality Control Resume
- Ensure safety, cleanliness, and compliance (SCC) at all time
- Provide leadership and direction to Quality Control supervisors and Managers and support teams to ensure high quality service
- Lead lab support topics in inspections conducted by external regulators and business partners
- Organize scientific data trend review, interpret data and draw reasonable conclusions
- Establish department operation schedule, plans, processes, budgets, departmental strategies, goals, objectives and metrics (Business continuity and long-term planning)
- Serve as a role model for behavior that is consistent with the mission, vision and values of the Regeneron organization with respect to the regeneron success factor: Trust, Respect, Teamwork, Transparency, and continuous improvement
8
Responsibilities For Director Quality Control Analytical Chemistry Resume
- Manages the Bioanalytical and Microbiological Services department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems
- Provides scientific and operational leadership in the areas of cGMP-compliant biopharmaceutical testing services that include protein characterization and release testing
- Develops scope of work and proposal for new and existing clients
- Manages TK/PK and ADA for large molecule studies scientifically and in regulation aspects (FDA, EMA, OECD, etc.)
- Works collaboratively with other site functions to ensure that analytical methods are aligned with process needs/capabilities and product requirements
- Keeps up to date on new technologies and changes in CMC and other regulatory requirements
- Represents Catalent with clients and prospective clients at on-site and external meetings, as required
9
Responsibilities For Executive Director Quality Control Resume
- Direct Reports: up to 10
- Total Site Staff: up to 50
- Accountable for overall budget and financial performance of the Quality Control function
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements
- Partner with other functional area leads across Process Development, Attributes Sciences, QC network and Product Quality to effectively execute method transfers and validations
- Assists with developing budget and monitoring expenditures
- Creates concise documentation of all testing and communicate test results
10
Responsibilities For Director Quality Control Quality Assurance Resume
- Serve as a QC SME on cGMP in-process, release, and/or stability testing
- Represent QC organization in related Network teams and company-wide initiatives
- Participate in regulatory inspections and site audits; lead QC activities during regulatory inspections, including inspection management and response strategies
- Manage individual contributors (professional employees)
- Contribute to the performance and results of a department
- Ensure decisions are guided by policies, procedures and business plan; receive guidance from manager
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