Director, Quality Assurance – GMP & Validation (Remote)

Travere Therapeutics; Salt Lake City (UT); Hybride; USD 150 000 - 195 000; Plein temps

Avantages offerts par ce poste

Premium health benefits

Stock options

Bonus program

Paid time off

Résumé du poste

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to guide GMP QA activities for contract manufacturing, testing, storage and distribution. You will lead validation efforts, approve VMP/VP/URS, and ensure regulatory compliance across CSPs with an emphasis on risk management and CAPA execution.

The role requires 8+ years in GMP QA, strong CFR/ICH knowledge, and ability to collaborate with Technical Operations.

Qualifications

• Bachelor's degree in Life Sciences; Master's preferred.
• 8+ years in GMP QA or Quality Systems in biotech/pharma.
• Strong knowledge of CFR/ICH and global regulations.
• Experience with vendor qualification and audits.
• Leadership and personnel development experience desired.

Responsabilités

• Provide QA guidance for GMP CSPs for Drug Substance/Product up to Phase 3.
• Oversee validation of Process, FUE, Shipping, Cleaning, Test Methods, and CSVs.
• Review and approve Validation Master Plans and URS/VPs.
• Support change control, deviations, OOS/OOT investigations and CAPAs.
• Collaborate with Technical Operations on CSP documentation and audits.
• Contribute to SOPs, work instructions and GxP compliance.
• Review Travere GxP documents and ensure regulatory alignment.
• Travel 10-25% domestically/internationally as needed.
• Lead, mentor and develop quality staff and project teams.

Connaissances

GMP Quality Assurance

cGMP CFR/ICH

Regulatory compliance

Quality Systems

Vendor qualification

Auditing

People management

Biotech/pharma experience

Formation

Bachelor's degree in Life Sciences

Master's degree preferred

Outils

Quality documentation systems

Description du poste

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to guide GMP QA activities for contract manufacturing, testing, storage and distribution. You will lead validation efforts, approve VMP/VP/URS, and ensure regulatory compliance across CSPs with an emphasis on risk management and CAPA execution.

The role requires 8+ years in GMP QA, strong CFR/ICH knowledge, and ability to collaborate with Technical Operations.