Thermo Fisher Scientific
Director of Quality - Biologicals and Chemicals Division
Grand Island, New York, USA · Director
Sponsorship not specified$175k-$205kDetected 1 day ago
Product ManagementProcess ImprovementPerformance ManagementGMPFDA RegulatoryCell CultureMedical DevicesLeadershipCommunicationLean ManufacturingRegulatory Affairs
About the role
- 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).
- Director of Quality, this role is accountable for the performance, compliance, and continuous improvement of the Manufacturing Quality function across the network.
Responsibilities
- Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model
- Drive harmonization and standardization of Quality processes, systems, and metrics across the network
- 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)
- Lead customer and regulatory interactions, including audits, inspections, and issue resolution
- Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network
- Maintain centralized Quality governance across the network while supporting site-level execution through matrix leadership.
- Drive Management Review processes at network level and ensure alignment with enterprise quality objectives.
- Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions
Requirements
- 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
- Experience in continuous improvement methodologies (Six Sigma, Lean)
- Ability to operate in a global, matrixed organization
- Demonstrated experience leading cross-functional and multi-site initiatives
- Strong leadership, communication, and decision-making skills
- Compensation and Benefits
- The salary range estimated for this position based in New York is $175,000.00-$205,000.00.
- 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:
- 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
Nice to have
- Bachelor's degree in Science, Engineering, or related field (advanced degree preferred)
Compensation
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
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