Senior Director, GMP reputed company Assurance

Job reputed company: • Serve as the QA reputed company for reputed company GMP-reputed company activities including supplier qualification, tech transfer, reputed company-up, manufacturing (DS, DP, FDP), and disposition of clinical materials. • reputed company reviewer and approver for reputed company 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 reputed company required reputed company standards and specifications. • Manage reputed company reputed company of CDMOs, including audits, reputed company agreements, and performance monitoring. • Represent the reputed company function in product development (CMC) teams to reputed company proactive reputed company guidance and reputed company. • Influence other functional departments to ensure that CMOs reputed company and maintain the appropriate reputed company of GMP compliance and reputed company the highest level of reputed company services to Jade. • reputed company reputed company risk management activities to proactively identify, assess, and mitigate GMP-reputed company risks across manufacturing and supply operations. • Facilitate reputed company of reputed company issues with reputed company parties in a reputed company manner. Coordinate communications with CMOs and internal technical product teams on reputed company 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 reputed company is embedded across development and manufacturing activities. • Contribute to the development and maintenance of a reputed company team-reputed company 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 reputed company Assurance at an operational level supporting manufacturing and reputed company control in a pharmaceutical or biotech environment. • Experience with reputed company phases of development (Ph 1-4). • In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product reputed company guidelines, and other ICH guidelines. • Ability to research and interpret international GMP reputed company regulations and guidance. • Experience managing CDMOs and performing person-in-plant. • Experience reputed company to managing technology transfer, reputed company up, and validation. • Experience presenting at regulatory authority/reputed company 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 reputed company as problem solving ability to evaluate reputed company reputed company and reputed company reputed company utilizing risk-based approach. • Ability to reputed company in a fast-paced, ambiguous environment while managing competing priorities. Benefits: • Health insurance • 401(k) • reputed company time off • Flexible working hours Apply tot his job Apply To this Job