Senior QA Director – GMP Compliance (Remote)

Travere Therapeutics; United States; Hybride; USD 150 000 - 195 000; Plein temps

Avantages offerts par ce poste

Premium health benefits

Work-life programs

Retirement plan with employer match

Paid time off

Résumé du poste

Travere Therapeutics, based in San Diego, seeks an Associate Director, Quality Assurance - Technical to provide and oversee technical quality and compliance for contract manufacturing, testing, storage and distribution, and related labs.

You will lead GMP QA functions, manage validation programs, review Validation Master Plans, URS, and PV protocols, and support CSPs while ensuring regulatory compliance and collaboration with Technical Operations.

Qualifications

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

Responsabilités

• Lead and oversee GMP QA functions for CSPs up to Phase 3.
• Manage validations: Process, Facilities, Utilities, Equipment, Shipping, Cleaning, Test Methods, and CV.
• Review validation docs: VMP, VP, URS, FMEA, PC/PU, PV.
• Support QA for CSPs: Change Control, Deviations/Quality Events, OOS/OOT, CAPA, Risk, Vendor qualification.
• Collaborate with Technical Operations; approve CSP documentation and regulatory compliance.
• Provide input to policies/SOPs; track timelines and progress.
• Travel 10–25% domestically and internationally.

Connaissances

GMP QA

Regulatory compliance

cGMP CFR/ICH

Leadership

Project management

Communication

Formation

Bachelor's degree in Life Sciences

Master's degree preferred

Description du poste

Travere Therapeutics, based in San Diego, seeks an Associate Director, Quality Assurance - Technical to provide and oversee technical quality and compliance for contract manufacturing, testing, storage and distribution, and related labs.

You will lead GMP QA functions, manage validation programs, review Validation Master Plans, URS, and PV protocols, and support CSPs while ensuring regulatory compliance and collaboration with Technical Operations.