Senior Director, Quality Assurance & GMP Compliance

Travere Therapeutics; Washington (District of Columbia); Remoto; USD 150.000 - 195.000; Tempo pieno

Vantaggi offerti da questo lavoro

Premium health benefits

Life insurance

Retirement plans with employer match

Descrizione del lavoro

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to provide and oversee technical quality guidance for contract manufacturing, testing, storage and distribution, and related activities up to Phase 3. The role requires 8+ years in GMP QA, a Life Sciences degree (Master's preferred), and hands-on experience with cGMPs, regulatory guidelines, and vendor qualification.

Travel of 10–25% domestically and internationally is expected, with on-site work in San Diego

Competenze

• Bachelor's degree in Life Sciences or related field required; Master's preferred.
• 8+ years of GMP QA or quality systems experience in biotech/pharma.

Mansioni

• Provide QA guidance and oversight of CSPs for Drug Substance/Product through Phase 3.
• Manage validation activities and documentation (VMP, VP, URS, FMEA, PV).
• Support change control, deviations, OOS/OOT, CAPA, risk management and vendor qualification.
• Collaborate with Technical Operations and ensure compliance with CFR/ICH and regulatory guidelines.

Conoscenze

cGMP knowledge

Regulatory knowledge

Leadership

Project management

Communication skills

Formazione

Bachelor's degree in Life Sciences

Master's degree preferred

Descrizione del lavoro

Travere Therapeutics is seeking an Associate Director, Quality Assurance - Technical to provide and oversee technical quality guidance for contract manufacturing, testing, storage and distribution, and related activities up to Phase 3. The role requires 8+ years in GMP QA, a Life Sciences degree (Master's preferred), and hands-on experience with cGMPs, regulatory guidelines, and vendor qualification.

Travel of 10–25% domestically and internationally is expected, with on-site work in San Diego