Role Overview

The Sr. Director, GMP Quality Assurance will provide leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. The Sr. Director, GMP Quality Assurance will collaborate closely with CMC, Quality Compliance and Analytical Development colleagues to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations. This individual will provide QA expertise and guidance in support of the development and product quality strategy for CMC teams and is responsible for execution of the day-to-day quality activities of CMO manufacturing, including but not limited to, disposition of all materials, deviation resolution, CAPA(s), change control(s), expiry/retest extension, product complaints and overall documentation supporting the suitability of batches. This individual is also responsible for ensuring staff execute within the Jade’s Quality Management System and adhere to policies and procedures. This role reports to the Executive Director of Quality and Compliance.

Key Responsibilities

• 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

Qualifications

• 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.

Position Location

This is a remote role; periodic travel to manufacturers and service providers and team and company events is required.

The anticipated salary range for candidates for this role is $255,000 - $275,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.