Jade Biosciences
Director, GMP Quality Assurance
Boston; Chicago; Remote; San Francisco; Seattle · Director
Sponsorship not specified$210k-$235kDetected 25 days ago
ExcelSupply ChainGMPFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationProblem SolvingOrganizational SkillsMicrosoft OfficeSharePoint
About the role
- This is a fully remote role, preferably based on the U.S. West Coast, with occasional domestic and international travel.
- The position reports to the Senior Director, GMP Quality Assurance.
Responsibilities
- 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
- 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
- Supports management of Quality Agreements, including project coordination, cross-functional review, and approval workflows
- 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
- 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
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)
- 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
- 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
- In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product related guidelines, and other ICH guidelines
- 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
Compensation
- The anticipated salary range for candidates for this role is $210,000 - $235,000.
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