<p>TITLE:</p> <p>Compliance Quality Assurance Manager</p> <p>Title: Compliance Quality Assurance Manager</p> <p>Reports To: Head, Site Quality, Raleigh</p> <p>Location: Raleigh, NC</p> <p>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.</p> <p>POSITION SUMMARY:</p> <p>The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA group. The scope of responsibilities includes the Validation team, Quality Systems, Compliance, Supplier Management, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, Health Authority Inspections and Final Product dispositions. This role will assure that the Validation & 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.</p> <p>ESSENTIAL FUNCTIONS:</p> <p>The responsibilities of this job include, but are not limited to, the following:</p> <ul> <li>Supervise, develop, manage, and train direct reports in Compliance Quality Assurance. </li><li>Effectively hire, develop, coach, manage, and motivate staff </li><li>Update and procure approval of job descriptions for department personnel. </li><li>Manage the validation team qualification, requalification, decommissioning and periodic review activities. </li><li>Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during weekly, monthly, and quarterly reviews. </li><li>Manage the APQR process and deliver approved reports on time per the approved schedule. </li><li>Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols. Manage periodic document reviews while meeting review dates. </li><li>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. </li><li>Establish annually the internal audit schedule and manage completion of the internal audits against the schedule. </li><li>Manage customer audits of the Raleigh site. </li><li>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. </li><li>Issue batch records to operations in support of the schedule. </li><li>Provide final disposition of Drug Product. </li><li>Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility. </li><li>Assure that the site and quality systems remain in compliance with changes to regulatory requirements. </li><li>Provide regulatory expertise to the technology transfer process, as needed. </li><li>Assure job objectives are met on a timely basis and escalate Quality issues to the Head of Quality. </li><li>Proactively drive a culture of continuous improvement. </li><li>Communicate effectively/efficiently with others in a professional manner. </li><li>Manage a wide variety of tasks under critical time constraints. </li></ul> <p>MINIMUM QUALIFICATIONS:</p> <p>License/Certifications: N/A</p> <p>Travel: less than 10%</p> <ul> <li>Bachelor of Science degree in a relevant scientific field from an accredited university required </li><li>Minimum ten (10) years of experience in pharmaceutical manufacturing required </li><li>Minimum five (5) years of progressive supervisory experience required </li><li>Prior experience leading validation activities including the setting validation strategies </li><li>Prior Quality System Management experience - including Track Wise and Veeva Vault </li><li>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. </li><li>Experience in a sterile manufacturing environment required. </li><li>Combination Product experience a plus. </li><li>Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs. </li><li>Advance computer skills, knowledgeable of data analysis, and statistical methods. </li><li>Successful implementation of continuous improvement opportunities. </li><li>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. </li><li>Excellent communication both written and oral and problem-solving skills </li><li>Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action. </li><li>Proven ability to work under pressure without compromising deliverables. </li><li>Collects, understands, interprets, and trends data on the quality system performance. </li><li>Strong computer skills including Microsoft platform and Visio. </li></ul> <p>COMPETENCIES/CONDUCT:</p> <p>In addition to the minimum qualifications, the employee will demonstrate:</p> <ul> <li>Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma principles. </li></ul> <p>BENEFITS:</p> <p>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:</p> <ul> <li> <p>3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st</p> </li><li> <p>401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay</p> </li><li> <p>U.S. Employee Stock Purchase Plan- 15% Discount</p> </li><li> <p>Comprehensive Medical, Dental, Vision, Life and Disability coverage</p> </li><li> <p>Health, Dependent Care and Limited Purpose Flex Spending and HSA options</p> </li><li> <p>Adoption assistance</p> </li><li> <p>Tuition reimbursement</p> </li><li> <p>Concierge/personal assistance services</p> </li><li> <p>Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage</p> </li><li> <p>Gym, fitness facility and cell phone discounts</p> </li></ul> <p>GUIDING PRINCIPLES:</p> <p>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.</p> <p>COMPLIANCE OBLIGATIONS:</p> <p>Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:</p> <p>Employee Obligations:</p> <ul> <li> <p>Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure</p> </li><li> <p>Risk IQ: Know what policies apply to your role and function and adhere to them.</p> </li><li> <p>Speak Up: If you see something, say something.</p> </li></ul> <p>Manager Obligations:</p> <ul> <li> <p>Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure</p> </li><li> <p>Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.</p> </li><li> <p>Model and reinforce a Speak Up culture on your team.</p> </li></ul> <p>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.</p> <p>EQUAL EMPLOYMENT OPPORTUNITY</p> <p>EOE/Minorities/Females/Vet/Disabled</p>