Indivior
TITLE:
IT Compliance Lead Reports To:
Director SAP & Compliance Location:
Richmond, VA or Raleigh, NC (Hybrid) Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. POSITION SUMMARY: The IT Compliance Lead is a subject matter expert on computer systems validation (CSV) and is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. This role partners with Business Units, IT teams, Quality, and Regulatory functions across multiple geographies to define computer system validation requirements and ensure IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: IT Compliance Governance: Determine strategy and roadmap for IT Compliance Mature IT Governance Keep abreast of IT Compliance trends and industry changes Team and Project Leadership: Partner with IT leadership and business functions on business initiatives Build strong and effective relationships with other IT teams to enable change initiatives. Lead and support IT Compliance team members to improve technical abilities and career development Procedures and Controls: Continue to mature IT related documentation. Review and approve IT governance and procedure documents. System Implementation and Validation Support: 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. Develop, or oversee the preparation of, key validation deliverables, gaining appropriate approvals from the Business Units, IT and Quality functions. Manage the delivery from project teams of key documentation that is required to support validation, escalating where necessary to the project manager. Develop, maintain, and execute training programs regarding Computer Systems Validation. Provide IT Governance oversight and/or coordination for the following areas: 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. Monitor and continuously improve the IT and Sarbanes Oxley Act (SOX) controls. Audit related activities: 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. MINIMUM QUALIFICATIONS: Education:
4-year Bachelor’s Degree Field of Study:
Scientific or technical discipline with focus on Information Technology or Bioscience Industry:
Pharmaceuticals / Life science Computer/Application Skills:
Windows, MS Office, ValGenesis, ServiceNow, Veeva Vault Quality, Adobe and DocuSign. COMPETENCIES/CONDUCT: Experience: 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. Attributes: 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. Fluency in English is essential. BENEFITS: 3 weeks’ vacation plus floating holidays and sick leave. 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions. U.S. Employee Stock Purchase Plan- 15% Discount. Comprehensive Medical, Dental, Vision, Life and Disability coverage. Adoption assistance. Tuition reimbursement. EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled
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IT Compliance Lead Reports To:
Director SAP & Compliance Location:
Richmond, VA or Raleigh, NC (Hybrid) Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. POSITION SUMMARY: The IT Compliance Lead is a subject matter expert on computer systems validation (CSV) and is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. This role partners with Business Units, IT teams, Quality, and Regulatory functions across multiple geographies to define computer system validation requirements and ensure IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: IT Compliance Governance: Determine strategy and roadmap for IT Compliance Mature IT Governance Keep abreast of IT Compliance trends and industry changes Team and Project Leadership: Partner with IT leadership and business functions on business initiatives Build strong and effective relationships with other IT teams to enable change initiatives. Lead and support IT Compliance team members to improve technical abilities and career development Procedures and Controls: Continue to mature IT related documentation. Review and approve IT governance and procedure documents. System Implementation and Validation Support: 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. Develop, or oversee the preparation of, key validation deliverables, gaining appropriate approvals from the Business Units, IT and Quality functions. Manage the delivery from project teams of key documentation that is required to support validation, escalating where necessary to the project manager. Develop, maintain, and execute training programs regarding Computer Systems Validation. Provide IT Governance oversight and/or coordination for the following areas: 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. Monitor and continuously improve the IT and Sarbanes Oxley Act (SOX) controls. Audit related activities: 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. MINIMUM QUALIFICATIONS: Education:
4-year Bachelor’s Degree Field of Study:
Scientific or technical discipline with focus on Information Technology or Bioscience Industry:
Pharmaceuticals / Life science Computer/Application Skills:
Windows, MS Office, ValGenesis, ServiceNow, Veeva Vault Quality, Adobe and DocuSign. COMPETENCIES/CONDUCT: Experience: 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. Attributes: 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. Fluency in English is essential. BENEFITS: 3 weeks’ vacation plus floating holidays and sick leave. 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions. U.S. Employee Stock Purchase Plan- 15% Discount. Comprehensive Medical, Dental, Vision, Life and Disability coverage. Adoption assistance. Tuition reimbursement. EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled
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