Job Description

Senior Director, Quality GLP, Research, and Biomarkers (Hybrid)

Apply locations Boston, MA | Full time | Posted 30+ Days Ago | Job requisition id REQ-24808

Job Description

The Senior Director, GLP Research, and Biomarkers will provide strategic direction and oversight of quality risk management strategies for specific product/therapeutic areas (e.g., Cystic Fibrosis). This role includes serving as the GCP Quality Program Lead, overseeing lifecycle risk reviews, implementing mitigation plans, and ensuring clinical quality and inspection readiness. The individual will lead Quality Management Reviews, ensuring transparency and effectiveness of risk controls, and align quality principles with organizational milestones.

This position requires fostering collaboration with stakeholders, aligning strategies with Quality leadership, and monitoring industry trends to enhance the quality system. The Senior Director will engage clinical/medical teams and cross-functional stakeholders to apply quality risk management approaches, such as Quality by Design, for operational excellence.

Key Duties and Responsibilities

1. Set strategic direction for quality risk management and mitigation.
2. Design and align program-specific quality strategies with global stakeholders.
3. Lead risk-based quality approaches, including Quality by Design and RBQM.
4. Develop and maintain the program quality plan.
5. Guide quality working groups to implement integrated quality plans.
6. Consult with business partners to incorporate best practices and new technologies.
7. Represent quality in cross-functional teams and governance bodies.
8. Manage complex quality issues proactively.
9. Lead inspection readiness strategies at key project milestones.
10. Advance the GCP QMS framework for operational performance.
11. Lead cross-QA operational reviews for transparency and improvement.
12. Partner on tools, metrics, and systems for operational accountability.
13. Benchmark industry practices and establish performance targets.
14. Coordinate strategic planning and execution across QA functions.

Knowledge and Skills

• Extensive knowledge of global health regulations and industry best practices.
• Experience applying risk-based quality principles in pharma.
• Strong operational, project management, and strategic planning skills.
• Proven leadership in developing and implementing quality strategies.
• Excellent communication and influence skills to promote a culture of quality.
• Operational excellence experience, including risk management methodologies.
• Analytical and problem-solving skills with data analysis proficiency.

Education and Experience

• M.S. degree with 10+ years of relevant experience, or
• B.S. degree with 15+ years of relevant experience.

We offer flexible work options: Hybrid (up to two days remote) or On-Site (five days/week with flexibility).

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