Type:

full-time

Job Description:

Director, GMP Quality (Retained)

Hybrid
3 days per week onsite
San Fran Bay Area We are retained with a clinical stage biotechnology company advancing a growing portfolio of small molecule medicines through clinical development.

As the organisation progresses its lead programs toward later stage development, it is expanding its Quality function and seeking a Director, GMP Quality to take a leadership role across GMP Quality Assurance and external manufacturing operations. This will be a highly visible position working closely with Technical Operations, CMC, Supply Chain, Regulatory Affairs and external manufacturing and testing partners. The successful candidate will help ensure the organisation has robust, phase appropriate GMP Quality processes capable of supporting clinical development today while continuing to build the systems and infrastructure required for late-stage development and future commercialization. Key Responsibilities Provide GMP Quality leadership across clinical-stage development programs. Partner closely with CMC, Technical Operations, Supply Chain and Regulatory colleagues to integrate Quality requirements into development and manufacturing activities. Provide Quality oversight of external manufacturers, contract testing laboratories and other GMP vendors. Oversee GMP activities spanning raw materials, drug substance, drug product, analytical testing, stability, packaging, labeling, storage and distribution. Support the review, approval and release of investigational materials in accordance with applicable regulatory and GMP requirements. Review and approve GMP documentation including manufacturing records, specifications, deviations, investigations, change controls and CAPAs. Lead or provide Quality oversight of product-impacting investigations and ensure appropriate root cause analysis and effective corrective and preventive actions. Establish risk-based, phase-appropriate Quality approaches as programs progress from clinical development toward registration and commercialization. Support vendor qualification, audits, Quality Agreements and ongoing performance management of external GMP partners. Identify GMP compliance risks proactively and work cross-functionally to develop practical mitigation strategies. Support the continued development and improvement of Quality Systems, SOPs and GMP processes. Provide Quality input into regulatory submissions and responses relating to manufacturing and product quality. Support inspection-readiness activities and play a key role during FDA and other global health authority inspections. Stay current with evolving GMP regulations, ICH guidance and industry expectations and translate these requirements into practical Quality strategies. Promote a culture in which Quality is viewed as a collaborative partner to development rather than solely a compliance function. What We're Looking For Bachelor's degree or higher in a scientific, pharmaceutical or related discipline. Approximately 8-12+ years of progressive Quality Assurance experience within the biotechnology or pharmaceutical industry. Significant hands-on experience within GMP Quality, ideally supporting clinical-stage small-molecule development. Strong understanding of GMP requirements across drug substance and drug product manufacturing. Experience overseeing outsourced manufacturing and testing through CMOs, CDMOs and contract laboratories. Demonstrated experience supporting the disposition or release of investigational materials. Strong experience with deviations, investigations, root cause analysis, CAPA and change control. Experience conducting or supporting GMP vendor audits and regulatory inspections. Strong understanding of FDA, ICH and relevant global GMP requirements. Experience working within an outsourced or heavily partner-dependent manufacturing model is highly desirable. Experience supporting programs as they move from early clinical development toward Phase 2, Phase 3 or commercialization would be particularly valuable. Ability to work effectively across CMC, Technical Operations, Regulatory Affairs, Supply Chain and other development functions. Strong judgment and the ability to balance compliance, product risk and development timelines. Excellent communication skills with the ability to influence both internal stakeholders and external partners. Comfortable operating in a growing biotechnology environment where processes and infrastructure continue to evolve. Why Join? This is an opportunity to join a clinical-stage organisation at an important point in its development. Rather than inheriting a large, mature commercial Quality organisation, the successful candidate will have the opportunity to shape how GMP Quality operates as the company progresses its clinical portfolio, expands its external manufacturing network and builds toward later-stage development. 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