Senior QA Leader – GMP Compliance & Validation (Remote)

Travere Therapeutics; Kansas City (MO); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health insurance

Company stock

Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director of Quality Assurance - Technical to lead GMP QA functions, oversee contract service providers, and ensure regulatory compliance for drug substance and drug product activities. The role focuses on validation, deviation handling, CAPAs, and risk management in a fast-paced biotech setting.

Ideal candidates hold a life sciences degree with 8+ years of GMP QA experience, strong cGMP knowledge, and excellent communication skills.

Qualifications

• Strong interpersonal and communication abilities are required.
• Broad knowledge of cGMPs (CFR/ICH) and applicable regulations.
• Experience in GMP Quality Assurance in biotech or pharmaceutical industry.

Responsibilities

• Lead QA GMP functions with oversight of CSPs for Drug Substance/Product toward Phase 3 and commercialization.
• Manage validations: process, facilities, utilities, equipment, shipping, cleaning, test methods, and computer system validation.
• Review Validation Master Plans, Validation Plans, URS, FMEA, PC/PU, PV protocols and reports.
• Support vendor qualification, change control, deviations, OOS/OOT investigations, CAPAs, risk management.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Job description

Travere Therapeutics is seeking an Associate Director of Quality Assurance - Technical to lead GMP QA functions, oversee contract service providers, and ensure regulatory compliance for drug substance and drug product activities. The role focuses on validation, deviation handling, CAPAs, and risk management in a fast-paced biotech setting.

Ideal candidates hold a life sciences degree with 8+ years of GMP QA experience, strong cGMP knowledge, and excellent communication skills.