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) or Raleigh, NC

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:

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