Director, Quality Assurance – Technical

Travere Therapeutics

Director of Quality Assurance responsible for GMP and compliance support in biopharmaceuticals. Leading validation efforts and managing contract service providers to ensure quality standards.

Posted 7/17/2026full-timeSan Diego • California • 🇺🇸 United StatesLead💰 $189,000 - $246,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance within FDA regulated environments, focusing on validation processes, compliance with cGMPs, and oversight of contract service providers in the pharmaceutical industry. Proficient in developing and executing validation plans and ensuring adherence to regulatory requirements.

Highest-signal resume keywords

Quality Assurance ManagementValidation Protocol DevelopmentCGMP ComplianceFDA Regulated Industry ExperienceContract Service Provider Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Master Plan (VMP)User Requirements Specifications (URS)Process Failure Mode and Effects Analysis (FMEA)Factory Acceptance Test (FAT)Site Acceptance Test (SAT)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Process Validation (PV)Risk Management

Soft Skills

Excellent Communication SkillsWell OrganizedFast LearnerAbility to Multi-taskIndependently Plan and Prioritize

Tools & Technologies

MS WordMS ExcelAdobePowerPoint

Industry Keywords

BiotechPharmaceutical IndustrySmall Molecule PharmaceuticalsRegulatory RequirementsGxP Documentation

About the role

Key responsibilities & impact

Lead, manage and perform critical Quality Assurance (QA) GMP functions providing oversight of GMP Contract Service Providers (CSPs) for Drug Substance and Drug Product activities/projects leading up to Phase 3 Process Validation and Commercialization
Leads validation efforts, projects, and action items including validations of: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning, Test Methods, and Computer System Validation
Develop, execute, review, approve and/or oversee various aspects of a validation activities, including but not limited to: Master Plan (VMP) Validation Plan (VP) User Requirements Specifications (URS) Process Failure Mode and Effects Analysis (FMEA) of the process Process Characterization (PC) and Process Understanding (PU) studies Factory Acceptance Test (FAT) Site Acceptance Test (SAT) Commissioning Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Process Validation (PV) protocols/reports
Direct Support of contract manufacturing, testing, storage and distribution organizations including, but not limited to: Change Control Deviations/Quality Events OOS/OOT investigations Corrective Actions and Preventive Actions Risk Management Vendor qualification and auditing Contractor qualification
Collaborate closely with the Technical Operations Department for review and approval of CSP documentation for the above functionality
Provide technical input to Travere Polices, SOPs, Work Instructions, etc., assuring internal needs are defined while complying with Regulatory requirements, Guidance and/or industry standards
Review and approve Travere GxP related documents as requested
Ensure compliance with applicable laws, regulations and guidelines for Travere Therapeutics’ contract manufacturing organizations
Participate in the project core teams and sub-teams as needed and assigned
Track progress versus timelines and goals

Requirements

What you’ll need

Bachelor’s degree in life science or related field of study required
A relevant technical or scientific field, Chemistry, Biology, or Chemical Engineering is preferred
10 years of relevant experience working in an FDA regulated industry in QA or a related field required with working experience in Biotech or Pharmaceutical industry
Excellent communication skills
fast learner
well organized
ability to independently plan, prioritize, multi-task, and follow-through on responsibilities
Computer skills including MSWord, Excel, Adobe, and PowerPoint
Working knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals

Benefits

Comp & perks

premium health
financial
work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off