Compliance Quality Assurance Manager

at  Indivior

TITLE:

Compliance Quality Assurance Manager
Title: Compliance Quality Assurance Manager
Reports To: Head, Site Quality, Raleigh
Location: Raleigh, NC
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:

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA group. The scope of responsibilities includes Quality Systems, Compliance, Supplier Management, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, Inspections, Validation and Final Product dispositions. This role will assure that the Quality Management System at the Raleigh site is in a state of control and compliant with regulatory requirements. The CQA Manager supports audits led by the Global audit function as well as any contracted audits 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. Finally, the CQA Manager prepares/reviews Quality Metrics for management review and makes recommendations for continuous improvement.

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel: less than 10%

• Bachelor of Science degree, minimum, in a relevant scientific field
• 10+ years of experience with 5+ years of progressive supervisory experience in pharmaceutical manufacturing
• Prior Quality System Management experience – including TrackWise and VeevaVault
• 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.
• Experience in a sterile manufacturing environment required.
• Combination Product experience a plus.
• Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs.
• Advance computer skills, knowledgeable of data analysis, and statistical methods.
• Successful implementation of continuous improvement opportunities.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.
• Excellent communication both written and oral and problem-solving skills
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Proven ability to work under pressure without compromising deliverables.
• Collects, understands, interprets, and trends data on the quality system performance.
• Strong computer skills including Microsoft platform and Visio.

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

• Supervise, develop, manage, and train direct reports in Compliance Quality Assurance. Effectively hire, develop, coach, manage, and motivate staff. Write and administer performance appraisals for department personnel. Update and procure approval of job descriptions for department personnel.
• Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during weekly, 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 audit against the schedule. Manage the approved vendor/supplier site list.
• Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.
• Manage customer audits of the Raleigh site.
• Assure 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. Provide regulatory support for Pre-Approval Inspection (PAI) preparation and inspection.
• Issue batch records to operations in support of the schedule.
• Provide final disposition of Drug Product.
• Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility.
• Assure 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 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.