<p><strong>The Role: </strong></p> <p><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <p><strong>Here's how you will contribute:</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments. </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities. <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. <span data-ccp-props="{"2013