Associate Director, Quality Assurance GMP/CSP Oversight

Travere Therapeutics; Minneapolis (MN); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to guide GMP/QA activities across contract manufacturing, testing, storage, and distribution.

The role leads validation oversight, change control, deviations and CAPA, with strong regulatory alignment and collaboration with Technical Operations to ensure cGMP compliance for global CSPs. This position requires 10-25% travel and will be based in San Diego.

Qualifications

• Bachelor’s degree required in life sciences; Master’s preferred.
• 8+ years in GMP QA or quality systems in biotech/pharma.
• Strong written and verbal communication skills.
• Experience with vendor qualification and audits.

Responsibilities

• Lead QA GMP functions with oversight of CSPs up to Phase 3 Process Validation and Commercialization.
• Manage validation efforts including Process, Facilities, Utilities, Equipment, Shipping, Cleaning, Test Methods, and Computer System Validation.
• Review and approve Validation Master Plans, Validation Plans, URS, FMEA, PC/PU studies, PV protocols/reports.
• Support change control, deviations/quality events, OOS/OOT investigations, CAPA, risk management, vendor qualification and auditing.
• Collaborate with Technical Operations to review CSP documentation and ensure regulatory compliance.

Skills

Quality Assurance

GMP knowledge

cGMP CFR/ICH

Regulatory compliance

Team leadership

Education

Bachelor's degree in life sciences

Job description

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to guide GMP/QA activities across contract manufacturing, testing, storage, and distribution.

The role leads validation oversight, change control, deviations and CAPA, with strong regulatory alignment and collaboration with Technical Operations to ensure cGMP compliance for global CSPs. This position requires 10-25% travel and will be based in San Diego.