Sr. Manager, Quality Validation

Title:

Sr. Manager, Quality Validation

• Title: Sr. Manager, Quality Validation
• Reports To: Head, Quality Operations, North America

Location: Richmond, VA

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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

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. 

Essential Functions:

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

Minimum Qualifications:

• 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.

Competencies/Conduct:

In addition to the minimum qualifications, the employee will demonstrate:

• Follow Indivior Guiding Principles
• Proficiency in Risk Assessment skills to support deviation investigations, change management and CAPA.

TRAVEL: Less than 10% travel.

Benefits:

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: 

• 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 
• 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 
• 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 
• Gym, fitness facility and cell phone discounts 

Guiding Principles:

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.  

Compliance Obligations:

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: 

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. 

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. 

Equal Employment Opportunity

Eoe/Minorities/Females/Vet/Disabled