Senior Manager, DPD Quality Performance & Governance (US Remote)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, we work together to accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. As the world leader in serving science, we are committed to delivering innovative solutions that help our customers make the world healthier, cleaner, and safer.

Pharma Services Group (PSG) is a leading provider of outsourced pharmaceutical development and manufacturing services. Within PSG, our Drug Product Development (DPD) division specializes in formulation development, clinical trial manufacturing, and commercial manufacturing of drug products.

DESCRIPTION:

The Senior Manager, DPD Quality Performance & Governance plays a crucial role in driving quality excellence across our Drug Product Development division. This position brings together deep expertise in Quality Control (QC), Quality Assurance (QA), and Quality Systems (QS) to elevate our quality performance and governance.

How you will make an impact:

• Drive divisional quality strategic initiatives and lead governance forums to monitor and improve quality performance across DPD sites globally.
• Analyze quality metrics, identify trends, and implement data-driven solutions to enhance compliance and operational excellence.
• Champion continuous improvement initiatives, leveraging Lean and Six Sigma methodologies to strengthen our quality processes.
• Influence cross-functional teams across multiple regions to align priorities and accelerate quality improvements.
• Support the implementation of enterprise-wide quality initiatives, including digital quality systems and data harmonization efforts.

What you will do:

• Support the Director in developing and executing the divisional quality strategic roadmap.
• Lead structured governance forums to monitor site and divisional quality performance, risks, and improvement actions.
• Analyze site and divisional quality metrics (e.g., deviations, CAPA, complaints, OOS/OOT, audit findings) to identify trends and drive preventive strategies.
• Develop standardized dashboards to improve transparency and accountability in quality performance.
• Lead cross-functional improvement projects that enhance compliance, reduce waste, and strengthen process robustness.
• Partner with Site Quality Heads and global stakeholders to align priorities and accelerate execution of quality initiatives.
• Convert high-level transformation goals into structured implementation plans for quality improvements.
• Ensure change initiatives are clearly communicated, understood, and embedded across the DPD organization.
• Foster a culture of proactive, measurable, and sustainable quality improvement.

REQUIREMENTS:

How you will get here:

• Bachelor's degree in Science, Engineering, Pharmacy, or related field; advanced degree preferred.
• 12+ years of experience in pharmaceutical, biotech, or similarly regulated industries.
• Strong functional experience across QC, QA, and Quality Systems (QS).
• Demonstrated experience leading cross-functional or global quality initiatives.
• Solid understanding of global regulatory requirements (FDA, EMA, ICH).
• Experience in trend analysis, governance leadership, and quality performance management.
• Lean / Six Sigma certification (Green or Black Belt preferred).

Knowledge, Skills, and Abilities:

• Proven ability to influence across multiple regions and cultures.
• Strong analytical and problem-solving skills with a data-driven approach.
• Excellent communication skills, able to simplify complex information for various audiences.
• Self-driven and highly motivated with a strong sense of ownership and urgency.
• Adaptable and comfortable with change in a dynamic environment.
• Collaborative leadership style with the ability to build trust across functions and levels.
• Strategic thinker with a focus on execution and follow-through.

Travel Requirements:

Up to 30% global travel may be required.

Location:

Remote / Flexible

This position reports to the Director, Quality Performance & Process Optimization.

At Thermo Fisher Scientific, each one of our 90,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Compensation and Benefits

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