Director, Technical QA & Validation (GMP)

Travere Therapeutics; United States; On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health benefits

Stock-based compensation

Paid time off and retirement plan with

employer match

Job summary

Travere Therapeutics is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support for contract manufacturing, testing, storage and distribution, and related labs up to Phase 3. You will oversee validation, change control, deviations, and CAPA activities while ensuring regulatory compliance.

Ideal candidates hold a life science degree with 10 years in FDA-regulated QA, prefer a Master’s, and bring strong cGMP knowledge.

Qualifications

• Bachelor’s degree in life science or related field required; Master’s preferred.
• 10 years of FDA-regulated QA experience in biotech or pharma.
• Experience supervising QA activities for CSPs and GMP validation.
• Strong knowledge of CFR/ICH guidelines and cGMP concepts.

Responsibilities

• Provide QA GMP oversight of CSPs for drug substance/product until Phase 3.
• Lead validation activities including PV, IQ/OQ/PQ, FAT/SAT.
• Manage change control, deviations, OOS/OOT investigations, CAPAs.
• Collaborate with Technical Operations to review CSP documentation.
• Support regulatory compliance and Travere policy development.
• Travel up to 25% domestically and internationally.

Skills

Excellent communication

Multi-tasking

Planning and prioritization

Team leadership

Problem-solving

Education

Bachelor’s degree in life science or related field

Master’s degree preferred

Tools

MS Word

Excel

Adobe

PowerPoint

Job description

Travere Therapeutics is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support for contract manufacturing, testing, storage and distribution, and related labs up to Phase 3. You will oversee validation, change control, deviations, and CAPA activities while ensuring regulatory compliance.

Ideal candidates hold a life science degree with 10 years in FDA-regulated QA, prefer a Master’s, and bring strong cGMP knowledge.