Senior Director, GMP Quality Assurance

Job Description: • Serve as the QA lead for all GMP-related activities including supplier qualification, tech transfer, scale-up, manufacturing (DS, DP, FDP), and disposition of clinical materials. • Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest, stability protocols, master batch records, method qualifications, etc. • Collaborate with CMC, Supply Chain and Program Management to ensure on time delivery of products. • Work directly with operating entities (internal and CMOs) to ensure that product(s) meet all required quality standards and specifications. • Manage quality oversight of CDMOs, including audits, quality agreements, and performance monitoring. • Represent the Quality function in product development (CMC) teams to provide proactive quality guidance and decisions. • Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide the highest level of quality services to Jade. • Lead quality risk management activities to proactively identify, assess, and mitigate GMP-related risks across manufacturing and supply operations. • Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CMOs and internal technical product teams on quality issues. • Review and approve CMC sections of regulatory filings as needed. • Collaborate cross-functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities. • Contribute to the development and maintenance of a positive team-focused company culture Requirements: • Bachelor’s degree and 17+ years of experience or a Master’s degree and 15+ years of experience in a scientific discipline or comparable experience. • At least 15 years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment. • Experience with all phases of development (Ph 1-4). • In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product related guidelines, and other ICH guidelines. • Ability to research and interpret international GMP related regulations and guidance. • Experience managing CDMOs and performing person-in-plant. • Experience related to managing technology transfer, scale up, and validation. • Experience presenting at regulatory authority/notified body inspections. • Experience supporting regulatory submissions (e.g. IND, BLA) and responding to health authority queries (e.g., FDA, EMA). • Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution. • Proven experience developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork. • Must have excellent verbal, written, interpersonal and organizational skills. • Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approach. • Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities. Benefits: • Health insurance • 401(k) • Paid time off • Flexible working hours Apply Now Apply Now