Associate Director, Quality Assurance – Technical

Travere Therapeutics

. Provide and support technical quality and compliance guidance and/or oversight of contract manufacturing, testing, storage, distribution, research, and laboratory organizations .

Posted 10/12/2026full-timeSan Diego • California • United StatesSenior💰 $150,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in GMP Quality Assurance and Quality Systems within the Biotech or Pharmaceutical Industry, with a strong focus on compliance, validation processes, and technical documentation. Proven ability to lead projects, manage multiple priorities, and develop personnel in a fast-paced environment.

Highest-signal resume keywords

GMP Quality AssuranceValidation Documentation ReviewCGMP KnowledgeBiotech Industry ExperienceProject Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Validation Master PlansUser Requirements SpecificationsProcess Validation ProtocolsRisk ManagementCAPA ManagementFMEAProcess CharacterizationQuality SystemsChange ControlAuditing

Soft Skills

Interpersonal SkillsOrganizational SkillsProblem-Solving SkillsCommunication SkillsAttention to Detail

Industry Keywords

Life SciencesPharmaceutical IndustryBiotechCGMPRegulatory ComplianceQuality AssuranceValidationSOPsGxPProcess Validation

About the role

Key responsibilities & impact

Provide and support technical quality and compliance guidance and/or oversight of contract manufacturing, testing, storage, distribution, research, and laboratory organizations
Lead, manage, and perform critical Quality Assurance GMP functions for contract service providers supporting Drug Substance and Drug Product activities through Phase 3 Process Validation and Commercialization
Manage validation efforts, projects, and action items for processes, facilities, utilities, equipment, shipping, cleaning, test methods, and computer systems
Review and approve validation documentation, including Validation Master Plans, Validation Plans, User Requirements Specifications, process FMEAs, Process Characterization and Process Understanding studies, and Process Validation protocols and reports
Support contract organizations with change controls, deviations/quality events, OOS/OOT investigations, CAPAs, risk management, vendor qualification and auditing, and contractor qualification
Collaborate with Technical Operations on review and approval of contract service provider documentation
Provide technical input to policies, SOPs, work instructions, and related documents
Review and approve Travere GxP-related documents
Ensure compliance with applicable laws, regulations, guidelines, and industry standards
Participate in project core teams and sub-teams
Track progress against timelines and goals
Perform additional assigned duties

Requirements

What you’ll need

Bachelor’s degree in a related Life Sciences discipline such as Chemistry, Biology, or Chemical Engineering required
Master’s degree preferred
Equivalent combination of education and applicable job experience may be considered
8+ years of direct experience in GMP Quality Assurance, Quality Systems, or a highly related field
Working experience in the Biotech or Pharmaceutical Industry
Broad working knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
Strong interpersonal and organizational skills
Excellent verbal and written communication skills
Previous line management and personnel development experience desired
Ability to independently identify and establish personnel development plans and skill development plans
Good problem-solving skills, strong sense of urgency, keen attention to detail
Ability to work independently and effectively manage multiple priorities under time and resource pressures
Ability to adapt to modifications and changes to project plans
Ability to travel 10-25% domestically and internationally
Ability to perform face-to-face work with colleagues and/or onsite in San Diego

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 benefits
Retirement plans with employer match
Generous paid time off
Short-term incentive
Long-term incentive compensation (company stock)