About the role
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob Description
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
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
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
Aplyr's read
Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
What's promising
- •Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
- •The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
- •Global presence provides diverse career opportunities across multiple regions and disciplines.
What to watch
- •High pressure and fast-paced environment may not suit everyone.
- •Complex organizational structure can lead to communication challenges.
- •Frequent acquisitions may result in uncertainty and change for employees.
Why Thermo Fisher
- •Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
- •The company plays a crucial role in global scientific advancements and healthcare solutions.
- •Strong focus on sustainability and corporate responsibility sets it apart in the industry.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Thermo Fisher
Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.
