Product Quality Manager (PQM)

Title

Product Quality Manager (PQM)

Title: Product Quality Manager (PQM)

Reports To: Reports to Head, Quality Operations, North America

Location: Richmond, VA preferred

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

Position Summary

This role is responsible to plan, co-ordinate, lead and manage the activities of the Operational Quality Section within the North American region, to ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested, and dispositioned in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.

Essential Functions

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

• Ensures that release documentation provided by third party suppliers complies with all required Indivior and Regulatory standards.
• Provides final INDV oversite of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
• Provides batch disposition of commercial product(s) manufactured in the US and ready for disposition into all authorized markets.
• Manages the quality elements of the Supply Chain for the commercial products manufactured in the US. This includes managing the quality relationship with the third-party contactors.
• Works with Supply personnel to foster dynamic working relationships with pre- wholesalers / wholesalers in North America to ensure continuity of patient supply of Indivior products within label requirements.
• Maintains Inspection Readiness of the Product program and supports management during inspections by competent authorities. Ensures all regulatory audit findings are formally closed out.
• Participates in internal audits and remediates any issues to agreed timelines.
• Executes external audits of North American suppliers per the approved audit schedule, as required. Follow up and complete and CAPAs required.
• Actively monitors and manages change controls, deviations, customer complaints and has quality oversight/approval to ensure compliance with the current Market Authorisations.
• Critically reviews investigations and responses for product quality complaints.
• Ensures Quality Technical Agreements between Indivior and any third parties are current, approved and are underpinned by regulatory requirements.
• Ensures third party activities in North America under Indivior control (manufacturing, packaging, distribution, co-packing etc) meet all regulatory and Indivior requirements.
• Performs periodic mock recall exercises according to local recall SOP’s.
• Reviews the learnings from all quality issues and failures to decide whether changes are required to the eQMS.
• Raises deviations as necessary and contributes to investigations, root cause analysis and CAPA identification on a case-to-case basis.
• Drives completion of deviations, ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business.
• Calculates and compiles the results of defect levels from each batch along with other identified Key Performance Indicators (KPIs). Communicates any trends to Indivior senior management as well as CMO governance team routinely.
• Performs Product Quality Reviews per approved schedule to ensure any quality improvements are identified, logged and tracked to completion.
• Participates in and provide quality input to project teams supporting new product launches.
• Participates in New and Existing Product development through the technical transfer process.
• Participates in Continuous Improvement activities including procedural enhancements to support the commercial activities in North America.
• In conjunction with Global Quality Management and the OPEX team, develops and carrys out training programs to ensure relevant Indivior policies/procedures and local QMS requirements are relayed to appropriate staff.
• Any other duties as determined by management to support North America Quality team.
• Some US and International travel required (approximately 10%) to support vendor relations, audit program and work with the global quality team.
  
  

Minimum Qualifications

License/Certifications: N/A

Travel: Less than 10% travel.

• Bachelor of Science degree, minimum, in a relevant scientific discipline.
• Proven track record, 10+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
• Direct experience in finished product dispositioning.
• Direct experience in reviewing manufacturing and packaging batch records as well as analytical testing results.
• Direct experience in Root Cause Analysis and critical thinking.
• Microbiological experience, a plus.
• Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Collects, understands, interprets, and trends data on quality system performance.
• Strong computer skills including Microsoft platform and Visio.
  
  

Competencies/Conduct

In addition to the minimum qualifications, the employee will demonstrate:

• Proficiency in Risk Assessment skills to support deviation investigations, change management and CAPA.
  
  

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 discount 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 and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
  
  

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.

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