Senior Director, GMP Quality

The Role:

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. Here's how you will contribute:

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.  Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation.  Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities.  

Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities.  Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events.  Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards.  

Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions.  Establish and monitor Quality performance indicators, identify evolving regulations and industry practices.

Leadership Qualities:

Brings deep GMP, GLP, manufacturing, and regulatory expertise with sound judgment, business partnership, and strong people leadership. Sets a clear Quality vision while remaining engaged in critical operational issues and making timely, well-reasoned decisions.  Identifies and prioritizes compliance and product risks, maintaining Quality’s objectivity and challenging decisions when patient safety, data integrity, or regulatory compliance may be compromised.  Provides practical, timely, and science-based guidance that enables development progress while protecting product quality,…