Senior Director, GMP Quality Assurance

Job Description:

• Lead development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system
• Provide independent Quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners
• Serve as final Quality authority for batch disposition and release within delegated responsibilities
• Review and approve batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other product-quality records
• Oversee process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes
• Establish and maintain risk-based qualification, auditing, monitoring, and requalification programs for GxP suppliers
• Establish quality agreements and governance processes with external partners
• Monitor quality performance through metrics, management review, trend analysis, and partner governance
• Lead regulatory inspection readiness and serve as primary Quality representative during inspections and health-authority interactions
• Oversee inspection responses and remediation commitments
• Ensure oversight of data integrity, electronic records, computerized systems, and documentation practices
• Lead or support critical quality events, investigations, complaints, recalls, market actions, and regulatory notifications
• Provide Quality expertise for business-development due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review
• Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support
• Build and lead a high-performing Quality organization and foster a culture of quality, accountability, compliance, transparency, and continuous improvement

Requirements:

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline
• Advanced degree preferred
• At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology industry
• Significant leadership responsibility for commercial products
• Experience leading Quality in a fully or substantially outsourced operating model
• Experience overseeing CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers
• Broad experience across multiple product modalities and manufacturing platforms
• Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product complaints, and inspection readiness
• Strong knowledge of global GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations
• Experience interacting directly with regulatory authorities and leading regulatory inspections, responses, remediation activities, and compliance commitments
• Ability to make independent, risk-based product-quality and compliance decisions using scientific and regulatory judgment
• Experience leading managers and professional staff and establishing Quality governance across cross-functional and external-partner organizations
• Strong executive presence and ability to communicate complex quality risks, recommendations, and decisions clearly
• Excellent leadership, negotiation, organizational, analytical, and problem-solving skills
• Ability to manage multiple priorities in a dynamic environment

Benefits:

• Discretionary annual bonus may be available based on individual and Company performance
• Equal opportunity employer
• Background screen required as a condition of employment