Director of Quality - Biologicals and Chemicals Division
Thermo Fisher Scientific
Director of Quality - Biologicals and Chemicals Division
Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob DescriptionPosition 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 Compensation and BenefitsThe 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 programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Locations
- USA, New York, Grand Island
Skills Required
- regulated industriesintermediate
- multi-siteintermediate
- GMPintermediate
- continuous improvement methodologiesintermediate
Required Qualifications
- Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred) (degree in science)
- Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred) (degree in science)
- 10+ years of Quality experience in regulated industries (experience, 10 years)
- 10+ years of Quality experience in regulated industries (experience, 10 years)
- 5+ years of leadership experience in multi-site or global quality organizations (experience, 5 years)
- 5+ years of leadership experience in multi-site or global quality organizations (experience, 5 years)
- Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems (experience)
- Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems (experience)
- Demonstrated experience leading cross-functional and multi-site initiatives (experience)
- Demonstrated experience leading cross-functional and multi-site initiatives (experience)
- Strong leadership, communication, and decision-making skills (experience)
- Strong leadership, communication, and decision-making skills (experience)
- Experience in continuous improvement methodologies (Six Sigma, Lean) (experience)
- Experience in continuous improvement methodologies (Six Sigma, Lean) (experience)
- Ability to operate in a global, matrixed organization (experience)
- Ability to operate in a global, matrixed organization (experience)
Responsibilities
- Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model
- 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
- 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
- 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.
- 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
- 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
- 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)
- 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
- 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
- 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
- Lead customer and regulatory interactions, including audits, inspections, and issue resolution
- Enable execution readiness for regional capacity expansion and new product introductions
- 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
- Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network
Benefits
- general: 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:
- general: A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- general: Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- general: 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
- general: Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- general: Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- general: A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- general: Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- general: 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
- general: Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- general: Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- general: For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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