Associate Director, Quality Assurance - Technical

Travere Therapeutics; United States; Hybride; USD 150 000 - 195 000; Plein temps

Avantages offerts par ce poste

Premium health benefits

Work-life programs

Retirement plan with employer match

Paid time off

Résumé du poste

Travere Therapeutics, based in San Diego, seeks an Associate Director, Quality Assurance - Technical to provide and oversee technical quality and compliance for contract manufacturing, testing, storage and distribution, and related labs.

You will lead GMP QA functions, manage validation programs, review Validation Master Plans, URS, and PV protocols, and support CSPs while ensuring regulatory compliance and collaboration with Technical Operations.

Qualifications

• Bachelor’s degree in Life Sciences; Master’s degree preferred.
• 8+ years of GMP QA or related experience in biotech/pharma.

Responsabilités

• Lead and oversee GMP QA functions for CSPs up to Phase 3.
• Manage validations: Process, Facilities, Utilities, Equipment, Shipping, Cleaning, Test Methods, and CV.
• Review validation docs: VMP, VP, URS, FMEA, PC/PU, PV.
• Support QA for CSPs: Change Control, Deviations/Quality Events, OOS/OOT, CAPA, Risk, Vendor qualification.
• Collaborate with Technical Operations; approve CSP documentation and regulatory compliance.
• Provide input to policies/SOPs; track timelines and progress.
• Travel 10–25% domestically and internationally.

Connaissances

GMP QA

Regulatory compliance

cGMP CFR/ICH

Leadership

Project management

Communication

Formation

Bachelor's degree in Life Sciences

Master's degree preferred

Description du poste

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 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 standard.
• 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

$150,000.00 - $195,000.00

• 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.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.