Associate Director, Quality Assurance - Technical

Travere•San Diego, CA

2d•Hybrid

About The Position

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. 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.

Requirements

Bachelor’s degree in related Life Sciences discipline such as Chemistry, Biology, or Chemical Engineering required.
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.
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.
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.

Nice To Haves

Master’s degree preferred.
Previous line management and personnel development experience with the ability to independently identify and establish personnel development plans and skill development plans is desired.

Responsibilities

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.