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# Associate Director, Quality Assurance - Technical

- **Company:** Travere Therapeutics, Inc.
- **Location:** Atlanta, GA, United States (Remote available)
- **Experience:** Expert
- **Salary:** $150,000.0 - $195,000.0
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, System Testing, GXP
- **Published:** October 14, 2026
- **Apply:** https://diversityjobs.com/career/18625339/Associate-Director-Quality-Assurance-Technical-Georgia-Atlanta

## About the Role

* Bachelor's degree in 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 or Quality Systems or a highly related field required with working experience in Biotech or Pharmaceutical Industry.

Additional Skills/Experience:

 * The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
 * Driven, intelligent, passionate about making a difference for patients with rare diseases
 * Broad working knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.
 * Strong interpersonal, organizational skills, and excellent verbal and written communication skills are required.
 * Previous line management and personnel development experience with the ability to independently identify and establish personnel development plans and skill development plans is desired.
 * Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
 * Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
 * Ability to travel 10-25% domestically and internationally.
 * All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

## Description

The Associate Director, Quality Assurance - Technical is responsible for providing and supporting technical quality and compliance guidance and/or oversight of the contract manufacturing, testing, storage and distribution, research and/or laboratory organizations., * 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.

 * Manage validation efforts, projects, and action items including validations of:
 + Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning, Test Methods, and Computer System Validation
 * Review and approve various aspects of validation activities, including but not limited to:
 + Validation 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
 + Process Validation (PV) protocols/reports
 * Support 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.
 * Additional duties assigned as needed.