Senior Manager, DPD Quality & Governance; US Remote

Work Schedule

Standard Office Hours (40/wk)

Office

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.

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.

• 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.

• 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.

• 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).

• 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.

Up to 30% global travel may be required.

Remote / Flexible

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

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