Sr. Director, GMP Quality Assurance
Skills
- Extensive operational GMP QA experience supporting manufacturing and QC in biotech/pharma.
- Experience managing CDMOs, performing person-in-plant and leading audits.
- Knowledge of FDA, EMA, ICH and device/combination product GMP guidance and ability to interpret international regulations.
- Hands-on experience with tech transfer, scale-up, validation and clinical supply operations.
- Proven ability to support regulatory submissions and interact with health authorities during inspections.
Responsibilities
- Lead QA oversight for GMP activities including supplier qualification, tech transfers, scale-up, manufacturing and disposition of clinical materials.
- Review and approve quality records (change controls, CAPAs, deviations, excursions, complaints, expiry/retest, stability protocols, MBRs, method qualifications).
- Manage quality oversight of CDMOs: audits, quality agreements, person-in-plant activities and performance monitoring.
- Collaborate with CMC, Supply Chain and Program Management to ensure timely delivery of product.
- Provide QA representation and proactive guidance on CMC/project teams and regulatory filings.
- Lead quality risk management and drive timely resolution of quality issues with internal and external stakeholders.
- Support regulatory inspections and submissions (IND/BLA) and respond to health authority queries as needed.
- Ensure team adherence to Jade’s Quality Management System, policies and procedures.
Education
- Bachelor’s degree in a scientific discipline (required) with extensive QA experience.
- Master’s degree preferred (reduced experience threshold).
Benefits
- Competitive base salary within stated range
- Remote-first role with periodic travel to CMOs and company events
- Opportunity to influence quality strategy at a clinical-stage biotech
- Collaborative, team-focused company culture and equal opportunity employer
Average salary estimate
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