Sr. Manager, Quality Validation

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.

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.

• 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…