POSITION SUMMARY

We are seeking an experienced Senior Director, Development Quality (GMP) who will be responsible for providing strategic and operational quality oversight for product development activities from early development through commercialization. This role ensures compliance with global GMP regulations and supports development, scale-up, and technology transfer of drug substance, drug product, and finished product.

This position requires extensive experience in GMP Quality Assurance, including oversight of CMC development, clinical manufacturing, and global supply, along with strong knowledge of regulatory expectations across all phases of development..

JOB FUNCTIONS/RESPONSIBILITIES

• Serve as a strategic Quality leader to support development and advancement of a compliant, phase-appropriate, and collaborative GMP quality culture across development and technical operations.
• Provide QA oversight of product development lifecycle activities, including drug substance (DS), drug product (DP), and finished product (FP) from early development through commercialization.
• Oversee and support GMP quality systems applicable to development, including deviations, CAPAs, change control, investigations, and product complaints.
• Provide QA support for clinical manufacturing, including batch record review/disposition and release of DS, DP, and FP for clinical use.
• Ensure quality oversight of process development, technology transfer, scale-up, and validation activities.
• Support preparation, review, and approval of CMC sections for regulatory submissions (e.g., IND, NDA, MAA) and responses to regulatory authority questions.
• Interface with regulatory agencies and support GMP inspections, including pre-approval inspections (PAIs) and general GMP inspections.
• Identify compliance risks within development and manufacturing activities and escalate issues to appropriate levels of management.
• Oversee and support GMP vendor management, including qualification, auditing, and ongoing oversight of CMOs, laboratories, and suppliers.
• Establish and maintain Quality/Technical Agreements with CMOs and development partners.
• Support new product introduction, acquisition, and integration activities from a GMP quality perspective.
• Support development and oversight of stability programs for investigational and commercial products.
• Develop, track, and trend quality metrics for reporting to Quality Management Review (QMR) and Annual Product Reviews (APR/APQR).
• Ensure inspection readiness across development and clinical manufacturing operations.
• Collaborate cross-functionally with Technical Operations, CMC, Regulatory Affairs, Supply Chain, and Manufacturing.
• Build, mentor, and lead a high-performing Development Quality team.
• Champion a culture of quality and inspection readiness across internal and external operations

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD) preferred.
• 15+ years of experience in the pharmaceutical/biotech industry, including 12+ years in GMP Quality Assurance.
• Strong expertise in global GMP regulations, including FDA, EMA (EudraLex), ICH guidelines, and Good Manufacturing Practices.
• Demonstrated experience supporting product development from early stage through commercialization, including clinical manufacturing.
• Strong knowledge of CMC development, process validation, technology transfer, and manufacturing operations.
• Experience supporting regulatory submissions (IND, NDA, MAA) and health authority inspections, including PAIs.
• Experience with GMP vendor oversight, including CMOs and contract laboratories.
• Proven leadership experience with the ability to build and develop high-performing teams.
• Strong understanding of pharmaceutical supply chain and lifecycle management.
• Experience with inspection readiness and continuous improvement of quality systems.
• Excellent communication, collaboration, and risk management skills.
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance

The salary range for this position is $275,657 to $310,847 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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