Remote: Senior Technical QA Lead – GMP Compliance

Travere Therapeutics; New York (NY); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to lead QA GMP functions overseeing CSPs for Drug Substance and Drug Product, up to Phase 3 and commercialization. The role requires deep cGMP knowledge and collaboration with Technical Operations to ensure regulatory compliance.

The ideal candidate will have 8+ years in GMP QA within biotech/pharma, strong leadership, and experience validating processes, methods, and systems.

Qualifications

• Bachelor's degree in Life Sciences; Master’s degree preferred.
• 8+ years of GMP QA or Quality Systems experience in biotech/pharma.

Responsibilities

• Lead QA GMP functions overseeing CSPs for Drug Substance & Drug Product up to Phase 3/Commercialization.
• Manage validation efforts: Process, Facilities, Utilities, Equipment, Shipping, Cleaning, Test Methods, and Computer System Validation.
• Review and approve Validation Master Plan, Validation Plan, URS, FMEA, PC/PU, PV protocols and reports.
• Support vendor qualification, deviations/quality events, OOS/OOT investigations, CAPA, risk management.
• Collaborate with Technical Operations for CSP documentation review and approval.
• Provide input to SOPs, GxP documents, ensuring regulatory compliance.
• Track progress against timelines and project goals.

Skills

cGMP knowledge

Interpersonal skills

Communication skills

Leadership

Education

Bachelors in Life Sciences

Masters preferred

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to lead QA GMP functions overseeing CSPs for Drug Substance and Drug Product, up to Phase 3 and commercialization. The role requires deep cGMP knowledge and collaboration with Technical Operations to ensure regulatory compliance.

The ideal candidate will have 8+ years in GMP QA within biotech/pharma, strong leadership, and experience validating processes, methods, and systems.