Indivior · 19 hours ago
IT Compliance Lead
Richmond, VA
Full-time
Onsite
Senior Level
7+ years expIndivior is a global pharmaceutical company dedicated to developing medicines for opioid use disorder. The IT Compliance Lead will serve as a subject matter expert on computer systems validation, responsible for developing and maintaining global policies and ensuring compliance with industry regulations while partnering with various teams across the organization.
Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial
Responsibilities
Determine strategy and roadmap for IT Compliance
Mature IT Governance
Keep abreast of IT Compliance trends and industry changes
Partner with IT leadership and business functions on business initiatives
Build strong and effective relationships with other IT teams to enable change initiatives
Leads and supports IT Compliance team members to improve technical abilities and career development
Continue to mature IT related documentation
Review and approve IT governance and procedure documents
Provide CSV and system implementation expertise to the Business Units and IT functions. This includes consideration of, and compliance with applicable: International Pharmaceutical industry regulations and guidance
Develop and maintain global Policies, Procedures, Standards, Guidelines and Templates to support the validation of business solutions
Develop, or oversee the preparation of, key validation deliverables (validation plans, validation reports, traceability matrices etc.), gaining appropriate approvals from the Business Units, IT and Quality functions
Manage the delivery (to agreed time and quality standards) from project teams of key documentation that is required to support validation (specifications, installation & testing evidence etc.), escalating where necessary to the project manager
Develop, maintain, and execute training programs regarding Computer Systems Validation
Coordinate IT risk reviews with the IT leadership team and relevant stakeholders
Identify regulatory compliance risks and proactively work with the Business Units, IT, Quality and Regulatory to address these risks
Provide compliance oversight to the IT change control process
Ensure consistency across the IT Training program
Provide administration, security and training support for systems utilized by IT compliance
Monitor and continuously improve the IT and Sarbanes Oxley Act (SOX) controls
Attend vendor audits as CSV and IT Compliance SME
Help to coordinate the completion of audit questionnaires by IT vendors
IT contact for internal, financial, and ITGC audits
Provide expertise and be key IT contact to the Business Units and IT in preparing for, and responding to, regulatory inspections
Perform periodic reviews of computer systems to evaluate and maintain compliance status
Qualification
Required
4-year Bachelor's Degree
Scientific or technical discipline with focus on Information Technology or Bioscience
Pharmaceuticals / Life science industry experience
Windows, MS Office, ValGenesis, ServiceNow, Veeva Vault Quality, Adobe and DocuSign computer/application skills
At least 7 years' experience in pharmaceutical business processes with in-house and outsourced manufacturing and the associated IT solutions
At least 7 years' experience dealing with pharmaceutical industry regulations and guidelines (including FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP)
7+ years' experience in a Computer Systems Validation role, with at least 3 years in a leadership role
Experience in GxP inspections performed by regulating authorities
Strong track record of contributing to projects and achieving results within a validated regulatory environment
Experience working with IT validation document repository (ValGenesis), electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard) and corporate quality management system (TrackWise and Veeva)
A working knowledge of IT application development, implementation and support processes within a regulatory environment including Project Planning, Software Lifecycle (Requirements, Design, Testing, and Implementation), Infrastructure Qualification
Involvement in multi-functional teams as a representative of the IT function and in technical teams representing regulatory compliance requirements
Experience in writing and reviewing project deliverables for validated applications
Understanding of Industry Guidance, standards and techniques
Customer and results orientated personality
Effective communication and team skills
Support, diagnostic and problem-solving skills experience
Flexibility in thinking/action and pragmatic in solving problems
Flexibility in role and approach, comfortable with adopting and adapting different roles as required
Fluency in English
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
2026-01-13
2026-01-09
Company data provided by crunchbase