Quality Product Lead
Thermo Fisher
Summary
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 Quality Product Lead, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement.
Job description
Discover Impactful Work
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 Quality Product Lead, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement.
A Day in the Life
- Serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements.
- Act as a key client-facing representative of Quality Assurance, partnering directly with customers from batch startup through disposition, providing timely communication regarding quality events, deviations, investigations, product impact assessments, and other quality-related matters.
- Build strong customer relationships through proactive engagement and transparent communication while ensuring quality and compliance expectations are consistently met.
- Contribute to the mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes.
Education/Experience
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 years of experience in quality assurance in GMP-regulated pharmaceutical/biotech environment required.
- Preferred Fields of Study: Chemistry, Biology, Microbiology, Engineering, or similar scientific, engineering or related technical field.
- Professional certifications valued (e.g. ASQ CQE, CQA).
- Experience with risk assessment methodologies and root cause analysis.
- Experience hosting regulatory inspections and customer audits preferred.
Knowledge, Skills, Abilities
- 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
- 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
- Data integrity and computer system validation experience preferred
- Ability to work effectively with diverse teams
- Customer-focused mindset with strong attention to detail
- Fluency in English required; additional languages valued
Requirements
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 years of experience in quality assurance in GMP-regulated pharmaceutical/biotech environment
- 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
- 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
- Fluency in English required
- Experience with risk assessment methodologies and root cause analysis
Benefits
- Medical, Dental & Vision
- Health incentive programs
- Employee assistance program
- Family support programs
- Commuter benefits
- Tuition reimbursement
- Paid time off
- Paid holidays
- Paid parental leave
- Accident insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) retirement savings plan
- Employee stock purchase plan
- Annual incentive bonus
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.