Associate Director, Quality Assurance - Technical

Department:

Location:

Position Summary:

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.   

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.
• 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. 

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

Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation: 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:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location. 

Travere will accept applications on an ongoing basis until a candidate is selected for the position.