Indivior
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.
Position Summary The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third‑party manufacturing, packaging, and testing. The role ensures compliance with regulatory requirements, industry standards, and develops company policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities. As the validation subject‑matter expert (SME) within Indivior, the manager interacts with local site validation teams to provide strategy and execution as needed, maintaining product quality, patient safety, and compliance with regulatory standards in the US and globally.
Essential Functions
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 reports, 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
Ensure 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 protocols, approve protocols, participate in FAT/SAT execution, review and approval of FAT/SAT final reports
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 with 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 SOPs, and 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 necessary CAPAs
Must have strong leadership and communication skills and be able to facilitate investigations across multiple functions and complete within required timelines
Drive completion of deviations and ensure CAPAs have been implemented and monitored for effectiveness to ensure Indivior has a quality‑centric continuously improving business
Participate in and provide quality input to project teams supporting new product launches
Participate in new and existing product development through the technical transfer and validation process
Participate in continuous improvement activities including procedural enhancements to support commercial activities in North America
In conjunction with Global Quality Management and the OPEX team, develop and carry 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 U.S. and international travel required (approximately 10%) to support vendor relations, audit program, and global quality team collaboration
Minimum Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field from an accredited university (Master’s preferred)
Minimum ten (10) years of pharmaceutical manufacturing or quality experience 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 and 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 implement measurable action plans
Strong leadership, communication, and listening skills
Excellent presentation, written, and oral communication skills
Proven ability to work under pressure without compromising deliverables
Collect, understand, interpret, and trend data on quality system performance
Strong computer and technical skills including Microsoft platform, SAP, Kaye, VEEVA, AI, validation equipment (e.g., Kaye Validator, Val Probes, Ellabs, thermocouples, building management systems, equipment HMI, filling equipment, autoclaves, HVACs, CTUs, portable monitoring devices, etc.)
Competencies/Conduct
Follow Indivior Guiding Principles
Proficiency in risk assessment skills to support deviation investigations, change management, and CAPA
Travel Less than 10% travel.
Benefits
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
Know what policies apply to your role and function and adhere to them (Risk IQ)
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
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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.
Position Summary The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third‑party manufacturing, packaging, and testing. The role ensures compliance with regulatory requirements, industry standards, and develops company policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities. As the validation subject‑matter expert (SME) within Indivior, the manager interacts with local site validation teams to provide strategy and execution as needed, maintaining product quality, patient safety, and compliance with regulatory standards in the US and globally.
Essential Functions
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 reports, 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
Ensure 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 protocols, approve protocols, participate in FAT/SAT execution, review and approval of FAT/SAT final reports
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 with 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 SOPs, and 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 necessary CAPAs
Must have strong leadership and communication skills and be able to facilitate investigations across multiple functions and complete within required timelines
Drive completion of deviations and ensure CAPAs have been implemented and monitored for effectiveness to ensure Indivior has a quality‑centric continuously improving business
Participate in and provide quality input to project teams supporting new product launches
Participate in new and existing product development through the technical transfer and validation process
Participate in continuous improvement activities including procedural enhancements to support commercial activities in North America
In conjunction with Global Quality Management and the OPEX team, develop and carry 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 U.S. and international travel required (approximately 10%) to support vendor relations, audit program, and global quality team collaboration
Minimum Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field from an accredited university (Master’s preferred)
Minimum ten (10) years of pharmaceutical manufacturing or quality experience 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 and 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 implement measurable action plans
Strong leadership, communication, and listening skills
Excellent presentation, written, and oral communication skills
Proven ability to work under pressure without compromising deliverables
Collect, understand, interpret, and trend data on quality system performance
Strong computer and technical skills including Microsoft platform, SAP, Kaye, VEEVA, AI, validation equipment (e.g., Kaye Validator, Val Probes, Ellabs, thermocouples, building management systems, equipment HMI, filling equipment, autoclaves, HVACs, CTUs, portable monitoring devices, etc.)
Competencies/Conduct
Follow Indivior Guiding Principles
Proficiency in risk assessment skills to support deviation investigations, change management, and CAPA
Travel Less than 10% travel.
Benefits
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
Know what policies apply to your role and function and adhere to them (Risk IQ)
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Pharmaceutical Manufacturing
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