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. Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs preferred. Advanced 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. Ability to collect, understand and interpret data trends on the quality system performance. Strong computer skills including Microsoft platform and Visio. HOW WE INVEST IN OUR PEOPLE 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:  Competitive PTO plus company closure from December 24th- January 1st  Eligible to participate in Indivior’s bonus program, based on company and individual performance Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan 401(k) and Profit-Sharing Plan- Company match U.S. Employee Stock Purchase Plan- 15% Discount  Comprehensive Medical, Dental, Vision, Life and Disability coverage  Health, Dependent Care and Limited Purpose Flex Spending and HSA options  Adoption assistance  Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage  Wellness programs as well as other discounts and perks OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT 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 behavior. Employee Obligations:  Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure  Risk IQ: Know what policies apply to your role and function and adhere to them.  Speak Up: If you see something, say something.  Manager Obligations:   Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure  Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.  Model and reinforce a Speak Up culture on your team.  EQUAL EMPLOYMENT OPPORTUNITY  EOE/Minorities/Females/Vet/Disabled are encouraged to apply! 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.  Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.   #LI-AC1 Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient. The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making. Indivior Guiding Principles: Focus on Patient Needs to Drive Decisions Believe that People’s Actions are Well Intended Seek the Wisdom of the Team Care Enough to Coach See it, Own it, Make it Happen Demonstrate Honesty and Integrity at All Times For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.