Job Description

Job Title: Product Quality Lead

Requisition ID: R-01169111

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.

How will you make an impact?

Provides leadership by performing the following: developing and empowering colleagues; encouraging relationships; putting self and colleagues in a position to succeed, meeting personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where colleagues are motivated to do their best.

What will you do?

CTx is an authority QA professional that provides leadership and experience with introduction of new client product/ activities/projects. Performs client quality project management, assists the client in Quality needs and understanding of Quality guidelines and Regulations, ensures commitments and adherence to Quality Agreements. We recognize a subject matter authority in one or more of the following Quality Assurance areas: cGMP and phase appropriate quality oversight, product development lifecycle, biopharmaceutical manufacturing, and/or regulatory affairs.

CTx is responsible for, batch record review, change control approval. Deviation support, disposition of clinical and Commercial Ops programs with respect to phase appropriate requirements and strategies. Personnel are responsible for adhering to appropriate standards during job performance including ensuring that training is current in all aspects. A Product Quality Lead

• Coordinates and ensures the successful day-to-day oversite of contract manufactured biologic molecule(s).
• Act as Liaison between the Client and Site during technology transfer of new products; ensuring development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from early phase development through transfer of support prior to Process Validation
• Monitors for quality related issues and coordinates resolutions.
• Review and aid in the establishments and maintenance of Client Quality Agreements
• Review and Approval of GMP documents in support of Clinical or Commercial manufacturing such as, but not limited to, Batch Records, Standard Operation Procedures, Technical Transfer Protocols, Deviations and Change Controls.
• Participates in Client audits as needed.
• Coordinates with PM on client communications. Attend customer Face to Face meetings and weekly meetings as needed.

How will you get here?

• BS/ BA in biology, biochemistry, chemistry or other science related field
• 8 years within a GMP Environment
• 5 years of experience within a Quality Role
• Proficient with computers (MS Office). Confirmed understanding of controlled documentation and data systems.
• In depth knowledge of cGMP regulations.

Knowledge, Skills, Abilities

• Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Proven track record to make key decisions.
• Technical writing skills.
• Technical knowledge of biopharmaceutical manufacturing is desirable.
• Microsoft Project/Project Management is desirable.
• Ability to aseptically gown and/or sterile gown as needed
• Ability to work within environmental clean rooms
• Ability to function in a constantly evolving environment and balance multiple priorities simultaneously

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.

Apply today! http://jobs.thermofisher.com

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 $81,600 - $124,800. 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

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