IT Compliance & CSV Senior Manager
Indivior
5 hours ago
Remote friendly (Richmond, VA)
United States
IT
IT Compliance & CSV Senior Manager (Hybrid: Richmond, VA or Raleigh, NC)
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 relationships with IT teams to enable change initiatives.
- Lead and support 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 Business Units and IT, ensuring compliance with applicable international pharmaceutical regulations/guidance and Indivior global/local policies, procedures, and standards.
- Develop and maintain global policies, procedures, standards, guidelines, and templates to support validation of business solutions.
- Develop/oversee key validation deliverables (validation plans/reports, traceability matrices, etc.) with appropriate approvals from Business Units, IT, and Quality.
- Manage timely, quality delivery of validation documentation (e.g., specifications, installation & testing evidence), escalating when necessary.
- Develop, maintain, and execute Computer Systems Validation training programs.
- Coordinate IT risk reviews; identify compliance risks and work with Business Units, IT, Quality, and Regulatory to address them.
- Provide compliance oversight for the IT change control process; ensure consistency across IT training.
- Provide administration, security, and training support for IT compliance systems.
- Monitor and continuously improve IT and Sarbanes-Oxley Act (SOX) controls.
- Attend vendor audits as CSV/IT Compliance SME; coordinate audit questionnaire completion by IT vendors.
- Serve as IT contact for internal, financial, and ITGC audits; act as key IT contact for Business Units and IT during regulatory inspections.
- Perform periodic reviews of computer systems to maintain compliance status.
Qualifications
- 4-year Bachelor’s degree in a scientific/technical discipline focused on IT or bioscience.
- Pharmaceuticals/life science experience.
- At least 7 years’ experience in pharmaceutical business processes with in-house and outsourced manufacturing and associated IT solutions.
- At least 7 years’ experience with pharmaceutical industry regulations and guidelines (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 with GxP inspections by regulating authorities.
- Strong track record delivering projects in a validated regulatory environment.
- Experience with ValGenesis, Adobe and DocuSign, AuditBoard, and TrackWise/Veeva quality systems.
- Working knowledge of IT application development/implementation/support processes in a regulated environment (project planning; software lifecycle: requirements, design, testing, implementation) and infrastructure qualification.
- Experience writing and reviewing deliverables for validated applications.
- Fluency in English.
Required/Preferred Skills
- Customer and results-oriented; effective communication and teamwork.
- Support, diagnostic, and problem-solving skills; pragmatic, flexible thinking/action.
Benefits (as stated)
- Competitive PTO; company closure Dec 24–Jan 1.
- Annual bonus.
- 401(k) with company match of 75% on first 6% + profit sharing equal to 4% of eligible pay.
- US Employee Stock Purchase Plan (15% discount).
- Comprehensive medical, dental, vision, life, and disability coverage; health/dependent care flex spending and HSA options.
- Adoption assistance; tuition reimbursement; concierge/personal assistance services.
- Voluntary benefits (Legal, Pet Insurance, Critical Illness) and wellness programs/discounts.
Application instructions: Not specified in the provided text.
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 relationships with IT teams to enable change initiatives.
- Lead and support 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 Business Units and IT, ensuring compliance with applicable international pharmaceutical regulations/guidance and Indivior global/local policies, procedures, and standards.
- Develop and maintain global policies, procedures, standards, guidelines, and templates to support validation of business solutions.
- Develop/oversee key validation deliverables (validation plans/reports, traceability matrices, etc.) with appropriate approvals from Business Units, IT, and Quality.
- Manage timely, quality delivery of validation documentation (e.g., specifications, installation & testing evidence), escalating when necessary.
- Develop, maintain, and execute Computer Systems Validation training programs.
- Coordinate IT risk reviews; identify compliance risks and work with Business Units, IT, Quality, and Regulatory to address them.
- Provide compliance oversight for the IT change control process; ensure consistency across IT training.
- Provide administration, security, and training support for IT compliance systems.
- Monitor and continuously improve IT and Sarbanes-Oxley Act (SOX) controls.
- Attend vendor audits as CSV/IT Compliance SME; coordinate audit questionnaire completion by IT vendors.
- Serve as IT contact for internal, financial, and ITGC audits; act as key IT contact for Business Units and IT during regulatory inspections.
- Perform periodic reviews of computer systems to maintain compliance status.
Qualifications
- 4-year Bachelor’s degree in a scientific/technical discipline focused on IT or bioscience.
- Pharmaceuticals/life science experience.
- At least 7 years’ experience in pharmaceutical business processes with in-house and outsourced manufacturing and associated IT solutions.
- At least 7 years’ experience with pharmaceutical industry regulations and guidelines (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 with GxP inspections by regulating authorities.
- Strong track record delivering projects in a validated regulatory environment.
- Experience with ValGenesis, Adobe and DocuSign, AuditBoard, and TrackWise/Veeva quality systems.
- Working knowledge of IT application development/implementation/support processes in a regulated environment (project planning; software lifecycle: requirements, design, testing, implementation) and infrastructure qualification.
- Experience writing and reviewing deliverables for validated applications.
- Fluency in English.
Required/Preferred Skills
- Customer and results-oriented; effective communication and teamwork.
- Support, diagnostic, and problem-solving skills; pragmatic, flexible thinking/action.
Benefits (as stated)
- Competitive PTO; company closure Dec 24–Jan 1.
- Annual bonus.
- 401(k) with company match of 75% on first 6% + profit sharing equal to 4% of eligible pay.
- US Employee Stock Purchase Plan (15% discount).
- Comprehensive medical, dental, vision, life, and disability coverage; health/dependent care flex spending and HSA options.
- Adoption assistance; tuition reimbursement; concierge/personal assistance services.
- Voluntary benefits (Legal, Pet Insurance, Critical Illness) and wellness programs/discounts.
Application instructions: Not specified in the provided text.