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Provide global quality leadership across the Cell Culture Media Network to ensure compliance, product quality, and harmonization across multiple manufacturing sites. Lead the network-wide Manufacturing Quality strategy and oversee QMS, laboratories, and product release functions.
Requires a Bachelor's degree in Science or Engineering with over 10 years of quality experience in regulated industries and 5+ years of multi-site leadership. Must possess deep knowledge of GMP, ISO standards, and FDA regulations.
Position Summary
TheDirector of Quality - Biologicals and Chemicals Divisiony provides global quality leadership across the Cell Culture Media Network, spanning multiple manufacturing sites (e.g., Grand Island, Inchinnan, Miami). Reporting to the Sr. Director of Quality, this role is accountable for the performance, compliance, and continuous improvement of the Manufacturing Quality function across the network. The Director ensures consistent application of Quality Management Systems, ensures product quality, drives harmonization across sites, and aligns quality strategy with business objectives, customer expectations, and regulatory requirements.
Key Responsibilities
Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model
Provide end-to-end Quality leadership across multiple manufacturing sites, ensuring compliance to ISO 13485, FDA 21 CFR 820, MDSAP, and applicable global standards
Drive harmonization and standardization of Quality processes, systems, and metrics across the network
Own network product Quality performance, including primary KPIs related to complaints, cost of poor quality (COPQ), and manufacturing health, and other metrics as required to ensure the health of manufacturing quality processes.
Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions
Partner with Operations, R&D, Regulatory Affairs, and Commercial teams to ensure successful product lifecycle management
Drive proactive quality engineering strategies and continuous improvement initiatives (e.g., Lean Six Sigma)
Oversee and govern complaint and nonconformance management across the media network sites
Serve as escalation point for critical quality issues and ensure timely containment and resolution
Lead customer and regulatory interactions, including audits, inspections, and issue resolution
Enable execution readiness for regional capacity expansion and new product introductions
Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network
Leadership & Governance
Maintain centralized Quality governance across the network while supporting site-level execution through matrix leadership. Ensure consistent decision-making, escalation pathways, and performance management across regions. Drive Management Review processes at network level and ensure alignment with enterprise quality objectives.
Qualifications
Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred)
10+ years of Quality experience in regulated industries
5+ years of leadership experience in multi-site or global quality organizations
Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems
Demonstrated experience leading cross-functional and multi-site initiatives
Strong leadership, communication, and decision-making skills
Experience in continuous improvement methodologies (Six Sigma, Lean)
Ability to operate in a global, matrixed organization
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:
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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
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