Associate Director, Quality Assurance - Technical

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.

Education/Experience Requirements

• 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.