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Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen 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.<h2>Roles and responsibilities:</h2>Leadership & Strategy<ul><li>Provide quality leadership and oversight for the greater Pharma Analytics network sites</li><li>Develop and implement strategic quality plans aligned with company goals and operational priorities</li><li>Serve as a member of the Pharma Analytics leadership team, actively shaping business strategy while ensuring compliance is never compromised</li><li>Lead complex teams within a matrix environment to promote a culture of quality accountability, collaboration, and compliance</li></ul><h2></h2><h2>Quality, Compliance & Regulatory Oversight</h2><ul><li>Be responsible for the quality management system, aligning with internal procedures and regulatory requirements and ensuring adherence throughout the product lifecycle</li><li>Serve as the Single Point of Contact for quality agreements, regulatory support, product quality complaints and critical issues, mitigating risks and ensuring successful outcomes</li><li>Coordinate compliance by ensuring site readiness for regulatory inspections, audits and oversight of industry standards</li><li>Provide quality input for periodic business and operational forums and report out on quality health at regular intervals</li></ul><h2></h2><h2>Operational Excellence & Customer Focus</h2><ul><li>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</li><li>Support business development activities and new product introduction by positioning Quality as a proactive strategic partner</li><li>Ensure customer quality requirements are met through extensive knowledge of Regulated products and by maintaining strong business relationships</li><li>Build strong, collaborative relationships with customer Quality counterparts, understanding their needs and translating them into continuous improvement initiatives</li></ul><h2></h2><h2>Education & Experience</h2><ul><li>Minimum Education Required: Bachelor's degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)</li><li>Professional certifications desired (ASQ, Lean Six Sigma, etc.)</li><li>7+ years of quality experience within the pharmaceutical, medical device, or regulated life sciences industry</li><li>5+ years of management/leadership experience required</li><li>Experience hosting regulatory inspections and customer audits</li></ul><h2></h2><h2>Knowledge, Skills, Abilities</h2><ul><li>Demonstrated ability to guide and impact operations in a matrix setting to attain desired results</li><li>Strong communication skills: ability to engage, collaborate and influence at all levels</li><li>Ability to think strategically with the capability to resolve technical problems using a growth mindset</li><li>Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency</li><li>Expert knowledge of Quality Management Systems, compliance standards (ISO, FDA, EMEA) and quality tools (FMEA, RCA, Risk Management)</li><li>Proficient with quality management software systems</li><li>Ability to travel up to 25%</li></ul>What We OfferCompetitive Salary:<ul><li>Pay rate based on experience</li><li>Annual performance-based bonus</li><li>Annual merit performance-based increase</li></ul>Excellent Benefits!<ul><li>Medical, Dental, & Vision benefits-effective Day 1</li><li>Paid Time Off (120 hours per year) + Designated Paid Holidays</li><li>401K Company Match up to 6%</li><li>Tuition Reimbursement – eligible after 90 days!</li><li>Employee Referral Bonus</li></ul>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.Compensation and BenefitsThe salary range estimated for this position based in Massachusetts is $140,000.00–$190,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>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</li><li>Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>For more information on our benefits, please visit: <a href="https://jobs.thermofisher.com/global/en/total-rewards" target="_blank">https://jobs.thermofisher.com/global/en/total-rewards</a>

Sr. Quality Assurance Manager

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Thermo Fisher Scientific

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