Senior Director, GMP Quality

The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements.

This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality.

• Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments.

• Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management.

• Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives.

• Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners. <span