Indivior

Senior IT Compliance, CSV Manager

Indivior

full-time

Posted on:

Location Type: Hybrid

Location: Richmond • North Carolina • Virginia • United States

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Job Level

Senior

About the role

  • 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.
  • Develop and maintain global Policies, Procedures, Standards, Guidelines and Templates to support the validation of business solutions.
  • Manage the delivery from project teams of key documentation that is required to support validation.
  • Develop, maintain, and execute training programs regarding Computer Systems Validation
  • Provide IT Governance oversight and/or coordination for IT risk reviews with 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.
  • Provide expertise and be key IT contact for regulatory inspections
  • Perform periodic reviews of computer systems to evaluate and maintain compliance status.

Requirements

  • 4-year Bachelor’s Degree Scientific or technical discipline with focus on Information Technology or Bioscience Pharmaceuticals / Life science
  • 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 (CVS) role
  • Minimum 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).
  • Working knowledge of IT application development, implementation and support processes within a regulatory environment including: Project Planning, Software Lifecycle (Requirements, Design, Testing, and Implementation), A working knowledge of 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 is essential including Customer and results orientated personality
  • Role requires 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 is essential.
Benefits
  • Competitive PTO plus company closure from December 24th- January 1st
  • Annual Bonus
  • 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
  • Wellness programs as well as other discounts and perks
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Computer Systems Validation (CSV)IT GovernanceProject PlanningSoftware LifecycleInfrastructure QualificationRegulatory CompliancePharmaceutical Business ProcessesGxP InspectionsAudit ManagementDocumentation Review
Soft Skills
LeadershipEffective CommunicationTeam CollaborationProblem-SolvingFlexibilityRelationship BuildingTraining DevelopmentStrategic ThinkingAdaptabilityResults Orientation