Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you'll do meaningful work that directly advances science and improves lives. In our BioProduction division, the products and solutions we deliver enable breakthroughs-from life-saving biologics to next-generation therapies. When our customers succeed, patients around the world benefit.

We are seeking a dynamic Sr. Quality Assurance Manager to play a critical leadership role in strengthening and stabilizing our quality organization during an important phase of growth and evolution. This is more than a functional leadership position-it's a high-visibility opportunity to shape strategy, elevate performance, and influence outcomes across the business.

In this role, you will partner closely with executive leadership, drive operational excellence, and build a strong, resilient quality culture. You'll gain direct exposure to senior leaders, benefit from mentorship at the highest levels, and position yourself for accelerated career growth within a global, science-driven organization.

If you are ready to step into a role where your leadership will make a measurable impact-and where your career can move to the next level-this is your opportunity to lead, influence, and grow in one of the most critical areas of our business.

Roles and responsibilities:

Leadership & Strategy

• Provide quality leadership and oversight for the greater Pharma Analytics network sites
• Develop and implement strategic quality plans aligned with company goals and operational priorities
• Serve as a member of the Pharma Analytics leadership team, actively shaping business strategy while ensuring compliance is never compromised
• Lead complex teams within a matrix environment to promote a culture of quality accountability, collaboration, and compliance

Quality, Compliance & Regulatory Oversight

• Be responsible for the quality management system, aligning with internal procedures and regulatory requirements and ensuring adherence throughout the product lifecycle
• Serve as the Single Point of Contact for quality agreements, regulatory support, product quality complaints and critical issues, mitigating risks and ensuring successful outcomes
• Coordinate compliance by ensuring site readiness for regulatory inspections, audits and oversight of industry standards
• Provide quality input for periodic business and operational forums and report out on quality health at regular intervals

Operational Excellence & Customer Focus

• Establish and manage tools for monitoring network quality trends and benchmarks, collaborating closely with Quality teams at network sites to ensure consistent and timely reporting
• Support business development activities and new product introduction by positioning Quality as a proactive strategic partner
• Ensure customer quality requirements are met through extensive knowledge of Regulated products and by maintaining strong business relationships
• Build strong, collaborative relationships with customer Quality counterparts, understanding their needs and translating them into continuous improvement initiatives

Education & Experience

• Minimum Education Required: Bachelor's degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)
• Professional certifications desired (ASQ, Lean Six Sigma, etc.)
• 7+ years of quality experience within the pharmaceutical, medical device, or regulated life sciences industry
• 5+ years of management/leadership experience required
• Experience hosting regulatory inspections and customer audits

Knowledge, Skills, Abilities

• Demonstrated ability to guide and impact operations in a matrix setting to attain desired results
• Strong communication skills: ability to engage, collaborate and influence at all levels
• Ability to think strategically with the capability to resolve technical problems using a growth mindset
• Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency
• Expert knowledge of Quality Management Systems, compliance standards (ISO, FDA, EMEA) and quality tools (FMEA, RCA, Risk Management)
• Proficient with quality management software systems
• Ability to travel up to 25%

What We Offer

Competitive Salary:

• Pay rate based on experience
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits!

• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off (120 hours per year) + Designated Paid Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement - eligible after 90 days!
• Employee Referral Bonus

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 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.