Director, Quality Assurance - Technical

About the role

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 and seek 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.

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.
• Lead validation efforts, projects, and action items including validations of:
  • Process
  • Facilities, Utilities, Equipment (FUE)
  • Shipping
  • Cleaning
  • Test Methods
  • Computer System Validation
• Develop, execute, review, approve, and/or oversee various aspects of 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.
• Provide technical input to Travere Policies, SOPs, Work Instructions, etc., ensuring 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 project core teams and sub-teams as needed and assigned.
• Track progress versus timelines and goals.
• Additional duties assigned as needed.

Requirements

• Bachelor’s degree in life science or related field of study required. A relevant technical or scientific field, such as 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, with experience in the Biotech or Pharmaceutical industry.

Skills

• Excellent communication skills; fast learner; well organized; ability to independently plan, prioritize, multi-task, and follow-through on responsibilities.
• Computer skills including MS Word, 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 pharmaceuticals.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills, and excellent verbal and written communication skills.
• Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, and respond to situations affecting staff.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently, and effectively manage multiple priorities.
• 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.

Benefits

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range: $189,000.00 - $246,000.00. Actual pay offered to a candidate will depend on factors including the candidate’s experience, education, skills, and location.