Quality Assurance Senior Manager Resume Sample
Casimir Konopelski
675 Cora Tunnel,
Houston,
TX
+1 (555) 880 5855
Work Experience
Quality Assurance Senior Manager
03/2016
-
PRESENT
Houston, TX
- Oversee end to end quality management in Asia
- Carry out quality resource planning and budget
- Manage 3rd party roving QC – relationship, performance & priorities
- Manage the transition from 3rd party roving QC to in house QC/QA
- Determine strategic priorities for satellites according to Corporate guidelines
- Plan and monitor execution in satellites
- Contribute in Quality Management Strategy
- Lead quality assurance & control within Asia
Senior Manager Systems Quality Assurance
09/2010
-
02/2016
Dallas, TX
- Define requirements and set priorities for manufacturing engineering
- A strong knowledge of the Bank’s platform applications
- Thorough knowledge and understanding of drug development and the clinical trial process
- Reasoning Ability: Ability to apply commonsense understanding to carry out instructions furnished in written, oral, diagram or schedule form. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Work Environment – The employee is occasionally exposed to risk of electrical shock, wet and/or humid conditions, fumes or airborne particles. The noise level is usually moderate
- Assist with development of infrastructure for the new Quality Assurance team including; policy/desktop procedures, reporting, and a database to track analyst’s work actions
- Effectively manage analysts to ensure they are continually monitoring the portfolios to identify any risk strategies or controls that are not performing as anticipated. Proactively provided feedback to the process owners if appropriate
- Assist with on-going projects supporting efforts to continually improve/enhance the Quality Assurance team
Senior Manager of Quality Assurance
01/2004
-
05/2010
Los Angeles, CA
- Judgmental lending experience with both consumer and business lending products
- Designing and managing the quality assurance processes
- Executing regular and ad-hoc data quality checks
- Gathering business and data requirements, producing project documentations and engaging corresponding teams (local risk teams, IB Technology teams, IRRM teams) to design and develop solutions per the requirements
- Collaborating with other stakeholders (such as GRM, Enterprise Data Management Office, Technology) to ensure that the IRRM data processes align with enterprise standards
- Manages the operation of the organization's total quality management (TQM) program
- Oversees the development of systematic approaches for assuring high quality services that meet customer needs
Education
University of Central Florida
1999 - 2003
Bachelor's Degree in Related Discipline
Professional Skills
- Proven leadership skills, organizational and project management experience
- Proven ability to effectively prioritize, escalate, and drive solutions to customer issues
- Effective communication skills are required, both written and verbal
- Demonstrated understanding of quality, manufacturing, supply chain fundamentals and risk management
- Demonstrate use and ability to apply critical thinking to problem solving
- Proven ability to lead difficult problem solving meetings with all functions, levels, and customer representatives, clearly articulating information
- Strong knowledge of Microsoft Exel, Powerpoint, Word and other designing software
How to write Quality Assurance Senior Manager Resume
Quality Assurance Senior Manager role is responsible for training, retail, credit, database, reporting, manufacturing, design, research, travel, government.
To write great resume for quality assurance senior manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Assurance Senior Manager Resume
The section contact information is important in your quality assurance senior manager 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 Quality Assurance Senior Manager Resume
The section work experience is an essential part of your quality assurance senior manager 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 quality assurance senior manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality assurance senior manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Assurance Senior Manager resume experience can include:
- Strong Quality Audit experience
- Several years’ experience leading direct employees, departments, and vendors
- Experience working as Software QA Manager
- Hands-on experience gained at a pharmaceutical or biotechnology company, covering both clinical and commercial products
- Experience implementing quality systems compliant with GXP and other FDA regulations
- Directs the activities of the Plant Quality and Sanitation programs in the effective/efficient execution of their functional responsibilities
Education on a Quality Assurance Senior Manager Resume
Make sure to make education a priority on your quality assurance senior manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality assurance senior manager 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 Quality Assurance Senior Manager Resume
When listing skills on your quality assurance senior manager 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 quality assurance senior manager skills:
- Collaborate with functional resource managers to effectively allocate and prioritize resources
- Establish and maintain Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) related to the quality of our solid unit dose product line
- Ensures effective sanitation and preventative pest control programs are maintained to assure compliance with Good Manufacturing Practices
- Operate the department in a highly productive, cost effective manner
- Ensuring effective defect management and issue resolution through all test phases
- Experience within a pharmaceutical manufacturing/packaging production facility
List of Typical Experience For a Quality Assurance Senior Manager Resume
1
Experience For Senior Manager Systems Quality Assurance Resume
- Oversees, QA Shift Managers to ensure assessment and development of talent and ongoing coaching to ensure successful performance
- Frequent travel for work, up to 66% of the time
- Leading and running testing efforts for multiple projects for a defined area of responsibility to successfully and consistently deliver high-quality software products within budget and schedule
- Leading or participating in continuous improvement initiatives to identify and implement tools and utilities that enhance testing capabilities and product quality
- Develops constructive customer relationship across stakeholders
2
Experience For Senior Manager, Portfolio Quality Assurance Resume
- Drives customer relationships and delivery of quality improvement recommendations for stakeholders; often influences outcomes of team decisions
- Quality Assurance: This role has overall responsibility for the performance of the Quality Assurance Operations Department, including safety, quality, production, and customer service. Reporting directly to this role are the QA Operations Managers, and Product Release Specialists
- Assists is formulating department strategy and annual goals/objectives that align with Production (OGSM – Objectives, Goals, Strategies, & Measures) and the overall Quality & Regulatory strategy for the site
- Create a safe, healthy and positive working environment for all associates working at AHP
- Support production to meet customer delivery commitments on time, first time, every time
- Reinforce and uphold compliance with cGMP’s, DEA and OSHA, and other applicable regulations
3
Experience For Senior Manager of Quality Assurance Resume
- Maintain a presence on all shifts
- Create a “Team Based” environment of engagement and inclusion
- Develop, manage and coach QA Operations managers and associates to improve and build bench strength responsible for recruiting, training and retaining quality associates
- Experience with Continuous Improvement Processes preferable
- Empower team to make decisions, problem-solve and implement changes, as needed
4
Experience For Senior Manager Global Quality Assurance Resume
- Provide personal, hands-on coaching of QA team members and floor associates in the principles of high performing work systems while holding all levels accountable for implementing and maintaining performance standards
- Develop a plan to conduct a Risk Analysis of Major cGMP's in the FDA system
- Conduct a risk analysis identifying critical, major and minor non-conformances as it relates to industry standard regulatory compliance while maintaining a firm focus on the ultimate business prospective
- Have difficult discussions and provide honest and candid performance feedback
- Make decisions and implement changes, as needed
5
Experience For Senior Manager Pharmacovigilance Quality Assurance Resume
- Need to be flexible to travel 15% of the time
- Establish and manage initiative communication and provide clear summaries, minutes and action items and translate into activities that drive progress
- Create quality deliverables with limited direction
- Track project status and manage project issues and risks
- Provide thought leadership and guidance in business and financial analysis, business value capture
- Partner with stakeholders and leverage network and relationships to identify requirements and opportunities
List of Typical Skills For a Quality Assurance Senior Manager Resume
1
Skills For Senior Manager Systems Quality Assurance Resume
- Good business acumen, high-level strategic thinking and strong analytical skills
- Strong interpersonal and influencing skills with a demonstrated ability to drive decisions
- Good working knowledge of MS Excel and PowerPoint
- Facilitate team meetings and operating reviews to maintain effective communication both within and outside the department
- Solid understanding of cGMP requirements and best pharmaceutical practices
- Demonstrated ability to structure, pragmatically scope, and solve abstract and complex problems
- At least ten years of progressive experience in a quality assurance role
2
Skills For Senior Manager, Portfolio Quality Assurance Resume
- Provide and be the mentor and coach for the team to ensure talent and skill development of the Q&MS team
- Maintaining quality-related score card metrics, developing and executing plans to meet and improve metrics
- Providing assistance to plants in developing and documenting quality best practices
- Providing appropriate training in all aspects of quality systems and programs to ensure compliance with established quality process/procedures
- Assisting plant personnel in executing quality procedures and drive sustainable improvements in the quality culture at all locations
- Identifying quality process improvement opportunities and recommending appropriate process changes
- Ensuring all staff is provided with frequent feedback and coaching in order to meet and exceed individual and team performance goals consistently
- Managing and supporting new ideas from staff to cultivate improvements through innovations
- Performing plant quality audits as needed
3
Skills For Senior Manager of Quality Assurance Resume
- Provide operational support to the Agile Quality lead including strategic planning and communications, project management and implementation activities
- Evangelize ITIL processes including change, incident, and problem management to create stable and robust
- In a Quality Assurance with a successful track record leading Quality Assurance teams
- Expert knowledge of GXP compliance (including 21 CFR, 210 and 211 GMP’s, and Part 11)
- Manage manpower, staffing, and budget to support team of QE's, SQE's, and CAE's
- Ensure alignment and cross functional collaboration of the Quality and Manufacturing organizations
- Organize, manage and facilitate network meeting to assure global alignment on Deviation/CAPA and Disposition expectations
4
Skills For Senior Manager Global Quality Assurance Resume
- Develop annual budget based on Amgen strategies, including opportunity/risk and cost-benefit analyses, and development of business cases
- Manage planning, execution and delivery of the projects
- Environment (Office, warehouse, etc.) – office and sometimes warehouse, repository or laboratory
- Audit and/or implementation of ISO 9001, AS9100 and AS9110 standards
- Assist the Shared Services Department on special projects
- Establish key contacts with upstream organizations that have a direct impact on Product Assurance
- Mentor new Test and Associate Test Engineers on assigned projects
5
Skills For Senior Manager Pharmacovigilance Quality Assurance Resume
- Attend Dev Code Reviews
- Direct, oversee and ensure program compliance with ISO 9001, corporate policies and procedures, quality contractual requirements, and any other referenced requirements as needed
- Develop, implement, or supervise the design of Quality Assurance and Quality Control policies and procedures including supplemental work instructions
- Respond to inquiries received from the customer and represent DI when interacting with customer
- Respond to and direct the completion of corrective action for complex Corrective Action Requests / Performance Assessment Reports received from the customer
- Facilitate and/or participate in continuous improvement activities
- Develop department budgets and ensure minimal variance
- Provide critical input and serve on new business proposal teams
- Ensure departmental reports (internal or external) are accurate, complete, and on-time
6
Skills For Senior Manager, Clinical Quality Assurance Resume
- Direct, oversee and ensure program compliance with ISO 9001, AS9100, AS9110, corporate policies and procedures, contractual requirements, and any other referenced requirements as needed
- Relevant pharmaceutical experience (i.e. drug development, clinical and/or non-clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance) including at least 2 years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits
- Communicate and collaborate cross-functionally
- Knowledge of Food Safety Modernization Act, HACCP, and/or UDSA regulatory compliance required
- Develops program communications to employees
- Evaluates and develops techniques designed to maintain awareness of SOP’s, and cGMPS’s
- Quality sponsor and interacts with customers on quality issues and is an advocate on the company’s quality concept
- Implements and monitors key performance indicators (KPI’s)
- Be an ‘ambassador’ for quality assurance and drive improvement
7
Skills For Senior Manager, Agency Quality Assurance Resume
- Knowledge and ability to ensure compliance with customer, regulatory, and environmental requirements such as RoHS, REACH, Sony Green, etc…
- Manages, develops and maintains Food Safety and Quality documentation (including programs, policies, specifications, HACCP/System Control Plans, Master Sanitation Schedule, and work documents)
- Ability and willingness to travel 10-25% of the time (primarily to New Jersey)
- Principle Liaison with internal and external customers
- Provide leadership and oversight to ensure successful and build and delivery of products and systems in both Orlando, Ocala, and Troy
8
Skills For Senior Manager Manufacturing Quality Assurance Resume
- Provide leadership to program team to ensure implementation of quality, contractual, technical and procedural requirements
- Engage with other functional organizations to drive process improvements and efficiencies
- Implement quality management system to ensure compliance to AS9100
- Manage quality improvements and initiatives over the AGMS Supply Chain
- Manage the CQA audit program for assigned projects, including coordination of project allocation and ensuring all project assessments, audit schedules and plans are completed and cover areas of high risk. Proactively flag potential issues to head of CQA
- Plan and conduct GCP / GLP external and internal audits to assess compliance with regulatory requirements, investigational plans and company standards for clinical trial and early development / non-clinical related activities
- Communicate audit findings to stakeholders ensuring understanding as well as collaborating with auditees to develop CAPAs, addressing root causes
- Assess GCP / GLP compliance risk areas and support development and implementation of risk mitigation measures
9
Skills For Senior Manager Risk Data Quality & Assurance Resume
- Perform quality reviews and provide input into clinical and non-clinical documents to ensure compliance with Jazz Pharmaceuticals SOPs and regulatory requirements
- Provide quality assurance oversight to assigned project teams including representation on internal project team meetings and vendor meetings
- Provide guidance, interpretation and information on GCP / GLP regulations, standards and quality systems
- Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections
- Review and assess regulatory inspection commitments and CAPA plans for robustness
- Provide leadership and oversight to ensure successful and build and delivery of products and systems in several MFC Sites.
- Supervises assigned plant quality managers
- Works directly with assigned plants to ensure the proper execution of quality & laboratory policies, procedures and methods
- Provides regular hands on support to plants, collects and reports quality key measures,
10
Skills For Credit Risk Quality Assurance Senior Manager Resume
- Conducts audits of both conditions and behaviors,
- Provides support for root cause analysis and associated corrective actions that drive measurable, continuous and sustainable improvements into food safety, product quality and regulatory compliance
- Ensuring quality policies and procedures are appropriately maintained, recorded and administered
- Acting as a technical resource and liaison between corporate quality and manufacturing operations, government agencies, customers and other internal and external stakeholders
- Assisting plants in reduction of non-conformances
- Acting as a technical resource for root cause investigation and resolution of quality issues at a plant level
- Regular and punctual attendance and physical presence in the workplace
Related to Quality Assurance Senior Manager Resume Samples
QA Director Resume Sample
Work Experience
• Responsible to develop Laboratory Product and F&B specific Quality strategy and goals in line with corporate polices. Responsible for identifying Quality considerations and communicating them to Laboratory Product and F&B senior team. Approve Laboratory Product and F&B manufacturing site’s plan to achieve goa...
Professional Skills
• Demonstrated leadership skills with strong...
• Leadership skills; Strong communication sk...
• Strong supervisory techniques, teamwork or...
Senior Quality Assurance Manager Resume Sample
Work Experience
• Promotes an associate relation’s environment that is consistent with long term management objectives
• Plans, organizes and allocates the department’s resources to meet department and company goals
• O Develops operational Quality strategy as a business partner to optimize th...
Professional Skills
• Excellent communication skills (oral and w...
• Innovative approach with excellent problem...
• Familiarity/experience in automated testin...
Senior Quality Manager Resume Sample
Work Experience
• What is this equation used to calculate Cpk LSL = (x – LSL) / 3s ?
• What is the final phase of the APQP development process?
• What is the primary difference between Cpk and Ppk?
• Typically requires 8 years’ experience in PCBA manufacturing, assembly ...
Professional Skills
• Excellent communication skills and strong ...
• Strong process skills and process document...
• Strong interpersonal skills including comm...
Senior Testing Resume Sample
Work Experience
• Proactively report critical issues and risks to management
• Update changes and maintain all documentation related to the manual / automated testing process
• Coordinate the test set-up for all assigned projects including environments, change control, and pre-defined data
&nb...
Professional Skills
• Proven ability to diagnostic and problem s...
• Good oral and written communication skills...
• Superior management skills and supervisory...
Lead, Quality Control Resume Sample
Work Experience
• Team members, Managers, and other departments to partner in the delivery of key accountabilities
• Internal business partners across operating groups to consult/advise/service in the delivery of key accountabilities
• Maintains Good Drivers Safety Record: Maintain a valid dri...
Professional Skills
• Strong troubleshooting skills to understan...
• Two to 3 years’ experience independently r...
• Experience with Aerosol testing and medica...
Software Quality Engineering Resume Sample
Work Experience
• Monitor SQE’s tasks and progress, reviewing games under development for technical risks, providing mitigation plans where/if possible and managing quality
• Work with Software Department Leadership to define and report relevant metrics
• Research and implement state-of-the-ar...
Professional Skills
• Excellent verbal and written communication...
• Strong interpersonal communication skills ...
• Good written and oral communication skills...