Director Quality
About The Position
As Director of Quality at Thermo Fisher Scientific, you'll lead strategic quality initiatives that directly impact healthcare and scientific advancement. You'll oversee comprehensive quality systems and operations while fostering a culture of continuous improvement and regulatory compliance. Working with site leadership and cross-functional teams, you'll drive quality excellence across manufacturing, testing, and product development activities. This role offers the opportunity to influence quality standards that ensure the safety and effectiveness of products while partnering with customers and regulatory authorities to maintain the highest levels of compliance.
Requirements
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in FDA-regulated industry (pharmaceutical, medical device, or diagnostics)
- 5+ years of quality management/leadership experience
- Extensive knowledge of cGMP, ISO standards (9001/13485), and global regulatory requirements
- Demonstrated success leading quality systems and regulatory inspections
- Strong expertise in risk management, CAPA, change control, and quality processes
- Experience managing customer relationships and quality agreements
- Experience building and developing effective quality teams
- Strong communication and presentation skills
- Demonstrated ability to implement organizational change
- Strong analytical and problem-solving capabilities
- Project management expertise
- Strategic planning and budget management experience
- Up to 30% travel required, including international
- Experience with quality management software systems
- Ability to work effectively in matrix environment and across multiple sites
Nice To Haves
- Preferred Fields of Study: Life Sciences, Engineering, Chemistry, or related scientific/technical field
- Professional certifications (ASQ, RAPS) advantageous
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
