Director, Quality Assurance - Technical

Department:

107100 Quality

Location:

San Diego, USA- Remote

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.

Position Summary:

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

 

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. 
• 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.
• Additional duties assigned as needed.

 

Education/Experience Requirements: 

• 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. Equivalent combination of education and applicable job experience may be considered. Master’s degree 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. 

 

Additional Skills/Experience: 

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• 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