Job Title: QA Supervisor

Requisition ID: R-01183506

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to live every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

At Microbial Manufacturing Services (MMS), a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Advanced Therapeutics business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

Leads and supervises site Quality Operations related programs and activities to support the contract/development manufacturing organization. This role leads all aspects of Quality on the Floor, Batch Record Generation, Review, Approval, and Disposition. Provides leadership, critical thinking, and results focus to efficiently meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to lead a fast-paced production environment and deliver outstanding service to our clients. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

What will you do?

• Actively participates as a member of the Quality Operations Leadership Team and partners with Sr. Management.
• Support Manufacturing and Quality Control Testing Operations during batch production, ensuring unexpected events (e.g. deviations and Out-of-Specifications) and CAPA are handled compliantly, reviewed, approved and in a timely manner within the Quality System (TrackWise).
• Review and approve documents including, but not limited to: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports, Material Data Packages and material specifications, Environmental Monitoring data, Alarm and Audit Trail Reports for process equipment/systems, etc.
• Partner with functional leaders to identify key performance metrics and develop a plan for routine measurement of batch record review and disposition cycle times.
• Balance problems of a diverse scope using a high degree of judgment and risk-based decision making.
• Advise senior management of critical issues.
• Champion process improvement concepts.
• Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.
• Support a state of continuous inspection readiness, including pre-audit walkthroughs and document review, serve as Subject Matter Expert/host for Quality Operations during audits.
• Promotes Thermo Fisher’s quality mission, vision and strategy.
• Ability to write reports, business correspondence and procedure manuals
• Strong interpersonal skills; ability to prioritize and lead through sophisticated processes/projects.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
• Ability to define problems, collect data, establish facts and draw valid conclusion.
• Coach and mentor direct reports; support development opportunities for staff.
• Flexibility to work off shift hours as needed. Support Night Shift Quality Operations staff.

How will you get there?

Education

• Bachelors in Biological Science or related technical field is minimum education requirement.

Experience:

• 5+ years of related experience in a Quality Unit.

• Extensive exposure to cGMP environment.
• Excellent interpersonal skills.
• Ability to multitask, strategically and tactically.
• Excellent knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Ability to function in a constantly evolving environment and balance multiple priorities simultaneously.
• Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

The salary range estimated for this position is $83,300 - $138,900. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Compensation and Benefits

The salary range estimated for this position based in California is $83,300.00–$138,900.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards