Director, QA & Technical Compliance (Remote)

Travere Therapeutics; Boston (MA); On-site; USD 189,000 - 246,000; Full time

Benefits offered by this job

Premium health & well-being benefits

Job summary

Travere Therapeutics in San Diego, remote, is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support across CSPs and manufacturing activities up to Phase 3.

You will lead validation efforts (FMEA, IQ/OQ/PQ, PV), manage change control, deviations, CAPAs, risk management, and vendor qualification while ensuring CFR/ICH compliance and collaboration with Technical Operations.

Qualifications

• Bachelor's degree in life science or related field required; Master's degree preferred.
• 10 years of relevant experience in an FDA-regulated industry in QA or related field.

Responsibilities

• Lead, manage and perform QA GMP functions providing oversight of CSPs for Drug Substance/Product up to Phase 3.
• Lead validation efforts including Process, FUE, Cleaning, Test Methods, and Computer System Validation.
• Develop and oversee Validation Master Plan, Validation Plan, URS, VMP, and PV protocols/reports.
• Direct Support of CSPs: Change Control, Deviations/Quality Events, OOS/OOT investigations, CAPAs.
• Collaborate with Technical Operations for review/approval of CSP documentation.
• Ensure compliance with CFR/ICH and other regulatory guidelines.
• Track progress against timelines and goals; participate in project core teams.

Education

Bachelor's degree in life science or related field

Master's degree preferred

Tools

MS Word

Excel

Adobe

PowerPoint

Job description

Travere Therapeutics in San Diego, remote, is seeking a Director of Quality Assurance - Technical to provide technical quality and compliance support across CSPs and manufacturing activities up to Phase 3.

You will lead validation efforts (FMEA, IQ/OQ/PQ, PV), manage change control, deviations, CAPAs, risk management, and vendor qualification while ensuring CFR/ICH compliance and collaboration with Technical Operations.