On a mission to transform the future of autoimmune care
Director, GMP Quality Assurance
Location
California + 4 moreAll locations: California | Illinois | New York | Massachusetts | Washington
Posted
16 hours ago
Salary
$210K - $235K / year
Seniority
Lead
Job Description
Director, GMP Quality Assurance
Jade Biosciences
• Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, manufacturing (cell bank, 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/reports, master batch records, method qualifications, etc. • Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery of products and compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations • Supports archival of documents/records, quality metrics and develop/maintain QA related tracking logs • Work directly with operating entities (internal and CMOs) to ensure that product(s) meet all required quality standards and specifications • Supports management of Quality Agreements, including project coordination, cross-functional review, and approval workflows • 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 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 • Participate in and support regulatory authority inspections and internal audits • Supports development/maintenance of Quality SOPs • Contribute to the development and maintenance of a positive team-focused company culture • Other duties, as assigned
Job Requirements
- Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in scientific discipline or comparable experience
- 10+ 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 including commercial)
- 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
- Experience related to managing technology transfer, scale up, and validation
- Experience supporting regulatory authority/notified body inspections
- Experience supporting regulatory submissions (e.g. IND, BLA) and responses 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
- Must be self-motivated with the ability to thrive in a fast-paced, ambiguous environment while managing competing priorities
- Excellent computer skills with working knowledge of MS Office such as Word and Excel, Visio and Adobe Acrobat professional, and familiarity with SharePoint
- Commitment to fostering a diverse and inclusive workplace.
Benefits
- Up to 15% travel to team and company events
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