GMDP Audit Manager

TITLE:

GMDP Audit Manager

Title: GMDP Audit Manager

Reporting To: Reports to Head of Global Quality, GxP Audit Programme

Location: Raleigh
 

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The GMDP Audit Manager is responsible for managing and maintaining the supplier qualification and maintenance processes for GMP and GDP commercial suppliers, ensuring compliance with global regulatory standards and company policies. This role involves planning and executing internal and external audits, overseeing supplier lifecycle management, and onboarding vendors to ensure clear compliance expectations and alignment with business needs. The GMDP Audit Manager will play a critical role in maintaining a compliant supply chain, optimizing vendor performance, and supporting the delivery of high-quality products.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

• Develop and execute internal and external GMDP audit programs using a risk-based approach.
• Ensure all audits comply with GMDP regulations and company standards.
• Manage audit resources, including internal and external auditors, and maintain a qualified auditor list.
• Prepare audit agendas, reports, and CAPA plans, ensuring timely documentation and follow-up.
• Monitor audit status, track CAPA implementation, and ensure issue resolution.

• Perform due diligence, initial qualification, requalification, and disqualification for suppliers.
• Maintain and update the Commercial GMDP Approved Supplier List (ASL).
• Oversee supplier transitions from R&D QA to Commercial QA during product launches.
• Ensure suppliers meet regulatory and business requirements throughout their lifecycle.

• Develop and manage CAPA plans with auditees, ensuring timely resolution of non-conformances.
• Suspend or withhold supplier qualifications for unresolved critical risks.
• Conduct risk assessments and implement mitigation strategies.

• Support preparation for regulatory inspections, ensuring audit documentation is accessible.
• Provide guidance during regulatory authority inspections of internal and external entities.

• Develop and maintain quality audit systems, ensuring adherence to relevant standards.
• Publish audit metrics and KPIs, including supplier risks and CAPA performance.
• Report audit outcomes and risks during management reviews.

• Train and mentor internal and external auditors to build a strong audit team.
• Provide training on quality processes.
• Lead process improvement initiatives within the GMP QA framework.
• Manage UK Auditor
• Ability to travel 25-30% domestic and international.

MINIMUM QUALIFICATIONS:

• Degree in Life Sciences, Pharmacy, or a related field.
• Auditing experience in a regulated environment, such as healthcare, pharmaceutical, or medical device industries.
• Broad experience in pharmaceutical manufacturing and distribution.
• Experience with vendor management
• Familiarity with virtual pharmaceutical supply chain models is advantageous.

COMPETENCIES/CONDUCT:

• Strong knowledge of EU GMP, GDP, FDA, and other regulatory requirements.
• Proven ability to manage audit programs, supplier qualifications, vendor agreements, and CAPAs.
• Exceptional organizational, communication, and leadership skills.
• Audit certification (e.g., ISO 9001, GxP) is desirable but not essential.

• Problem-solving and decision-making skills.
• Ability to work independently and collaboratively.
• Strong focus on compliance and continuous improvement.

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts

GUIDING PRINCIPLES:

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.  The employee may perform other functions that may be assigned.  Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled