Sr. Director, GMP Quality Assurance

Role Summary

The Sr. Director, GMP Quality Assurance will provide leadership, direction, and Quality Assurance oversight of contract manufacturers and service providers for cell bank, drug substance, drug product, packaging and labeling, and distribution of multiple products. This role collaborates with CMC, Quality Compliance, and Analytical Development to ensure compliance with cGMP regulations and guidelines across manufacturing and supply operations. It includes day-to-day QA activities for CMO manufacturing, disposition of materials, deviation resolution, CAPAs, change controls, expiry/retest extensions, product complaints, and documentation supporting batch suitability. The role reports to the Executive Director of Quality and Compliance.

Responsibilities

• Serve as the QA lead for 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 products meet 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 CMOs achieve GMP compliance and provide high-quality services to Jade.
• Lead quality risk management activities to identify, assess, and mitigate GMP-related risks across manufacturing and supply operations.
• Facilitate resolution of quality issues with internal and external parties; coordinate communications with CMOs and internal 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 to embed quality across development and manufacturing activities.
• Contribute to a positive, team-focused company culture.

Qualifications

• Bachelor‚Äôs degree and 17+ years of experience or Master‚Äôs degree and 15+ years 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 pharma/biotech.
• Experience with all phases of development (Ph 1-4).
• In-depth knowledge of GMP FDA, EMA regulations, device and combo product guidelines, and ICH guidelines; ability to interpret international GMP regulations.
• Experience managing CDMOs and performing person-in-plant.
• Experience with 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 (FDA, EMA).
• Strategic thinker with a hands-on approach; strong partnership development with cross-functional stakeholders.
• Excellent verbal, written, interpersonal, and organizational skills; strong communication and problem-solving abilities using a risk-based approach.
• Ability to thrive in a fast-paced, ambiguous environment with competing priorities.

Skills

• Quality leadership in GMP environments
• Regulatory knowledge (FDA, EMA, ICH)
• CDMO management and supplier qualification
• Quality systems, CAPA, deviation, change control, and document control
• Risk management and inspection readiness
• Cross-functional collaboration and stakeholder management

Education

• Bachelor‚Äôs degree required; advanced degree preferred as noted in Qualifications.

Additional Requirements

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