Director, GMP Quality Assurance

Role Overview

• 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

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.

Tech Stack

• Pug

Benefits

• Up to 15% travel to team and company events