Senior Director, GMP Quality Assurance

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, GMP Quality Assurance based in the United States. We are seeking an accomplished quality assurance executive to lead pharmaceutical quality strategy and compliance across a growing biopharmaceutical portfolio. In this senior leadership role, you will provide independent Quality oversight for clinical-stage and future commercial products, ensuring adherence to global regulatory requirements and Good Manufacturing Practices (GMP). Operating within a fully outsourced model, you will oversee external manufacturing partners, laboratories, and other regulated service providers while maintaining rigorous quality standards. You will guide product disposition, quality system governance, regulatory inspection readiness, and risk management across the product lifecycle. Working closely with executive leadership and external partners, you will build a strong culture of accountability, transparency, and continuous improvement. This is an opportunity to influence critical development and commercial milestones while helping protect patients and preserve product quality.

As the senior Quality leader, you will establish and maintain robust quality systems, provide independent oversight of outsourced GxP activities, and ensure that products and operations meet applicable regulatory requirements. You will also lead quality governance, manage significant compliance risks, and develop the organizational capabilities needed to support long-term portfolio growth. Lead pharmaceutical quality systems: Develop, implement, govern, and continuously improve the pharmaceutical quality system, including document control, training, change control, deviations, investigations, corrective and preventive actions (CAPAs), complaints, management reviews, and product-quality reviews. Oversee external manufacturing and testing: Provide independent Quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners. Manage product disposition and release: Serve as the final Quality authority for batch disposition and release within delegated responsibilities, ensuring compliance with applicable market-specific requirements, including Qualified Person certification where required. Review and approve quality documentation: Provide timely, risk-based review of batch records, analytical results, investigations, change controls, CAPAs, specifications, validation documentation, and other records affecting product quality or disposition. Support product and process lifecycle activities: Oversee process and analytical changes, technology transfers, validation, new product introductions, product acquisitions, and post-approval changes. Manage external partner quality: Establish risk-based qualification, auditing, monitoring, and requalification programs for contract development and manufacturing organizations (CDMOs), contract laboratories, packaging providers, distributors, and other GxP suppliers. Establish quality agreements: Define responsibilities, communication protocols, performance expectations, and escalation pathways with external partners. Monitor quality performance and risks: Develop meaningful quality metrics, conduct trend analysis and management reviews, and ensure significant risks and adverse trends are escalated and addressed appropriately. Lead inspection readiness: Serve as the primary Quality representative during regulatory inspections and health-authority interactions, overseeing inspection preparation, responses, remediation plans, and compliance commitments. Protect data integrity: Ensure appropriate oversight of electronic records, computerized systems, documentation practices, and data integrity across internal operations and the external GxP network. Manage critical quality events: Lead or support significant investigations, product-quality complaints, recalls, market actions, and regulatory notifications. Support strategic business activities: Provide Quality expertise for business development, due diligence, licensing, product acquisitions, investigator-initiated studies, and promotional review, as applicable. Manage resources and budgets: Develop and oversee the Quality Affairs budget, resource plans, organizational capabilities, and external support requirements. Build a high-performing Quality organization: Lead managers and professional staff while promoting compliance, accountability, transparency, sound decision-making, and continuous improvement. Exercise independent Quality authority: Escalate significant concerns, reject product, or suspend regulated activities when necessary to protect patients, product quality, data integrity, and regulatory compliance. Requirements: The ideal candidate is a seasoned pharmaceutical or biotechnology Quality executive with extensive experience overseeing commercial products, complex manufacturing networks, and global regulatory compliance. You should bring sound scientific judgment, strong executive leadership, and the ability to make independent, risk-based decisions while guiding cross-functional teams and external partners. Education: Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline. An advanced degree is preferred. Industry experience: At least 15 years of progressively responsible Quality experience in the pharmaceutical or biotechnology industry, including significant leadership responsibility for commercial products. Outsourced operating models: Demonstrated experience leading Quality within a fully or substantially outsourced environment, including oversight of CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers. Broad technical expertise: Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPAs, validation oversight, product complaints, and regulatory inspection readiness. Global regulatory knowledge: Strong understanding of applicable GMP and Good Distribution Practice (GDP) requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and FDA and EMA expectations. Regulatory inspection leadership: Experience interacting directly with regulatory authorities and successfully leading inspections, responses, remediation activities, and compliance commitments. Independent decision-making: Ability to make risk-based product-quality and compliance decisions grounded in scientific evidence, regulatory requirements, and sound professional judgment. People and organizational leadership: Proven experience leading managers and professional staff and establishing effective Quality governance across cross-functional teams and external partners. Executive communication: Strong presence and the ability to explain complex quality risks, recommendations, and decisions clearly to senior leadership, boards, regulators, external partners, and technical teams. Leadership and problem-solving: Excellent negotiation, organizational, analytical, and problem-solving skills, with the ability to manage competing priorities in a dynamic environment. Commitment to quality and patient safety: A demonstrated focus on regulatory compliance, data integrity, product quality, and continuous improvement. Benefits: Annual base salary: $250,000–$320,000, depending on experience, qualifications, geographic location, and other job-related factors permitted by law. Performance-based compensation: A discretionary annual bonus may be available based on individual and company performance. Remote work: Fully remote position within the United States. Senior leadership opportunity: The chance to shape Quality strategy, lead a high-performing organization, and influence critical clinical and commercial milestones. Strategic impact: The opportunity to strengthen global compliance, oversee external manufacturing partnerships, and contribute to the development of therapies addressing unmet medical needs.