Manager, Compliance Quality Assurance

TITLE:

Manager, Compliance Quality Assurance

WHO WE ARE

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 OUD, and we are 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.  

POSITION SUMMARY:

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team.   The scope of responsibilities includes managing site Quality events within the eQuality Systems, ensuring site Compliance, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, site self-inspections, and Bulk Product dispositions.  This role will liaise with the Head of Quality Systems & OPEX to ensure that processes developed at the Raleigh site ensure a state of control and are compliant with regulatory requirements set forth in Indivior’s Quality Management System.  The CQA Manager will support audits directed by the Global audit function and maintains the site in a constant state of inspection readiness. The CQA Manager will be expected to support the Head of Site Quality in regulatory site inspections. The CQA Manager prepares/reviews site Quality Metrics for management review and makes recommendations for continuous improvement.

WHAT YOU WILL DO

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

• Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release.  

• Effectively hire, coach, and motivate staff.  

• Write and administer performance appraisals for department personnel.  

• Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during monthly and quarterly reviews.

• Manage the APQR process and deliver approved reports on time per the approved schedule.

• Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols.  Manage periodic document reviews while meeting review dates.

• Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audits against the schedule.  Manage the approved vendor/supplier site list for the site.

• Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.

• Ensure the site maintains a constant state of inspection readiness.  Lead the back room during regulatory inspections and customer audits.  Act as back up to the inspection host.

• Issue batch records to operations in support of the schedule.

• Ensure timely disposition of semi-finished Drug Product.

• Ability to conduct root cause analysis and risk assessments.

• Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility.

• Ensure that the site and quality systems remain in compliance with changes to regulatory requirements.

• Provide regulatory expertise to the technology transfer process, as needed.

• Assure job objectives are met on a timely basis and escalate quality issues to the Site Head of Quality.

• Proactively drive a culture of continuous improvement.

• Communicate effectively/efficiently with others in a professional manner.

• Manage a wide variety of tasks under critical time constraints.

• Other activities as required.

WHAT YOU WILL BRING

• Bachelor of Science degree in a relevant scientific field required.

• Minimum ten (10) years of experience in pharmaceutical manufacturing required.

• Minimum five (5) years of progressive supervisory experience in pharmaceutical manufacturing required.

• Prior Quality System Management experience.  Experience in VeevaVault preferred.

• In depth knowledge and experience with USP, CFR, ICH, and ISO regulations as well as current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S preferred.

• Experience in a sterile manufacturing environment required.

• Combination Product experience a plus.

• Knowled