Quality Product Lead
About The Position
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 life 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. DESCRIPTION: Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As a Senior Quality Specialist, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement. You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements. This role offers the opportunity to directly contribute to our mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes.
Requirements
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience within quality assurance in GMP-regulated pharmaceutical/biotech environment preferred.
- Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211, ICH guidelines.
- Proven expertise in quality systems including investigations, CAPAs, change control, document control.
- Experience with risk assessment methodologies and root cause analysis.
- Proficiency with quality management systems and standard office software.
- Strong technical writing and documentation skills.
- Excellent verbal/written communication and interpersonal abilities.
- Demonstrated project management and organizational capabilities.
- Strong analytical and problem-solving skills.
- Ability to work independently and collaborate effectively in cross-functional teams.
- Ability to work effectively with diverse teams.
- Customer-focused mindset with strong attention to detail.
- Fluency in English required.
Nice To Haves
- Professional certifications valued (e.g. ASQ CQE, CQA)
- Experience hosting regulatory inspections and customer audits preferred
- Data integrity and computer system validation experience preferred
- Additional languages valued
Responsibilities
- Provide technical leadership and oversight for GMP manufacturing environments.
- Work cross-functionally to drive quality excellence and continuous improvement.
- Serve as a subject matter expert.
- Conduct risk assessments.
- Lead investigations.
- Manage CAPAs.
- Ensure adherence to global regulatory requirements.
- Host regulatory inspections and customer audits.
Benefits
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- 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
- Short- and long-term disability
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
