Indivior · 2 months ago
Sr. Manager, Quality Validation
Richmond, VA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expIndivior is a global pharmaceutical company dedicated to transforming opioid use disorder into a recognized and treated chronic disease. The Sr. Manager, Quality Validation is responsible for developing validation strategies for manufacturing and packaging while ensuring compliance with regulatory requirements and industry standards. This role involves collaboration with various teams to maintain product quality and patient safety within the US and globally.
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Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences or related field in a relevant scientific discipline from an accredited university required
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
Preferred
Master's degree preferred
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
Company
Indivior
Indivior is a specialty pharmaceuticals business.
1001-5000 employees
H1B Sponsorship
Indivior has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (5)
2022 (6)
2021 (4)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Piper SandlerOaktree Capital Management
2024-11-05Post Ipo Debt· $400M
2024-07-12Post Ipo Equity
2014-12-23IPO
Leadership Team
Mark Crossley
Chief Executive Officer
Recent News
2026-01-09
2026-01-09
2025-12-24
Company data provided by crunchbase