Sr. Quality Assurance Manager

Thermo Fisher Scientific•Bedford, MA

1d•$140,000 - $190,000•Onsite

About The Position

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.

Requirements

Minimum Education Required: Bachelor's degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)
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%

Nice To Haves

Professional certifications desired (ASQ, Lean Six Sigma, etc.)

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