Sr. Manager, Quality Validation

TITLE: Sr. Manager, Quality Validation 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. This is a hybrid role located at our Richmond, VA HQ POSITION SUMMARY The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing. This role ensures compliance with regulatory requirements, industry standards, and develops company policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities. The Sr. Manager, Quality Validation will serve as the validation subject matter expert (SME) within Indivior. The Sr. Manager, Quality Validation interacts with the local site validation teams to provide the strategy as well as execution, as needed. This position is critical for maintaining product quality, patient safety and compliance with regulatory standards within the US and Most of World. WHAT YOU WILL DO The responsibilities of this job include, but are not limited to, the following: Develop, implement and maintain the Indivior validation policy and validation master plan Lead validation activities for process validation, sterile manufacturing, oral solid dose, utilities, and computer systems Oversee validation activities at third party CMO/CPO to ensure compliance with internal and regulatory requirements Author, execute, review and approve validation protocols, summary report and supporting documentation Ensure validation activities meet Annex 1, FDA, EMA and ICH requirements Maintain validation systems in compliance with cGMPs and global regulations Support regulatory inspections, audits, and due diligence reviews as the SME for validation Partner with CMOs to ensure validation programs are robust and compliant Collaborate cross functionally with Quality, Manufacturing, Regulatory and IT teams to align validation strategies with Indivior goals Implement risk-based validation approach as applicable to improve efficiency Identify and drive opportunities for system and process improvements Ensures that validation documentation provided by third party suppliers complies with all required Indivior and Regulatory standards Lead or support the development of User Requirement Specifications (URSs) Lead or support factory acceptance tests and site acceptance tests, review protocol, approve protocol, participate in FAT/SAT execution, review and approval FAT/SAT final report Lead or support risk assessments associated with validation equipment and process validation activities Support engineering studies led by the Technical Operations/Engineering Teams/CMC internally and externally w/CMOs/CPOs Support any regulatory requests pertaining to updates to the regulatory dossier associated with validation Ensure annual validation and requalification activities are performed internally and externally Lead or support Installation Qualification/Operational Qualification/Performance Qualification and Process Validation (PV) activities Maintain the Indivior Validation Policy, internal validation master plans (VMPs), validation standard operating procedures (SOPs), work instructions (WI) Must have strong technical understanding of GxP pharmaceutical equipment, facilities and processes Must have strong root cause analysis skills for authoring deviations and identifying the necessary CAPAs Must have strong leadership and communication and able to facilitate investigations across multiple functions and complete within the required timelines Drives completion of deviations and ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business Participates in and provide quality input to project teams supporting new product launches Participates in New and Existing Product development through the technical transfer and validation process Participates in Continuous Improvement activities including procedural enhancements to support the commercial activities in North America In conjunction with Global Quality Management and the OPEX team, develops and carries out training programs to ensure relevant Indivior policies/procedures and local QMS requirements are relayed to appropriate staff Any other duties as determined by management to support North America Quality team. Some US and International travel required (approximately 10%) to support vendor relations, audit program and work with the global quality team WHAT YOU WILL BRING Bachelor’s degree in Engineering, Life Sciences or related field in a relevant scientific discipline from an accredited university required (Master’s degree preferred) Minimum ten (10) years of pharmaceutical manufacturing or quality with at least eight (8) years in validation, executing and leading validation teams in a regulated industry such as FDA, pharmaceutical or medical device Direct experience in root cause analysis (RCA) and critical thinking Strong sterile and microbiological experience Strong understanding of small molecule products Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S, ISO, etc. Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action Strong Leadership, communication and listening skills Excellent communication skills - presentation, written and oral Proven ability to work under pressure without compromising deliverables Collects, understands, interprets, and trends data on quality system performance Strong computer and technical skills including Microsoft platform, SAP, Kaye, VEEVA, AI, validation equipment i.e. Kaye Validator, Val Probes, ellabs, thermocouples, building management (BMS) systems, equipment HMI, filling equipment, autoclaves, HVACs, CTUs, portable monitoring devices, etc. 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.