Product Quality Manager (PQM)

TITLE:

Product Quality Manager (PQM)

Title: Product Quality Manager (PQM)

Reports To: Head, Quality Operations, North America

Location: Richmond, VA preferred

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). 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 OUD. Indivior is dedicated to transforming OUD 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. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

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 and leads investigations, root cause analysis and CAPA identification on a case-to-case basis. 
• Must be proficient in root cause analysis and identifying the appropriate solutions/corrective and preventive actions
• Must have strong leadership and communication and able to facilitate investigations across multiple functions and complete within the required timelines
• Drives completion of deviations and 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 E