IT Compliance & CSV Senior Manager

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WHO WE ARE

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION SUMMARY:

The IT Compliance & CSV Senior Manager 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 ensures IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures.

This hybrid role could be located in Richmond, VA or Raleigh, NC

WHAT YOU WILL DO

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.

• Leads and supports 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. This includes consideration of, and compliance with applicable:

  International Pharmaceutical industry regulations and guidance

  INDIVIOR Global / Local policies, procedures and standards

• 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

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.

• Provide administration, security and training support for systems utilized by IT compliance

• 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.

WHAT YOU WILL BRING

• 4-year Bachelor’s Degree Scientific or technical discipline with focus on Information Technology or Bioscience

• Pharmaceuticals / Life science

• Windows, MS Office, ValGenesis, ServiceNow, Veeva Vault Quality, Adobe and DocuSign.

• 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.

HOW WE INVEST IN OUR PEOPLE

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 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

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure

• Risk IQ: Know what policies apply to your role and function and adhere to them.

• Speak Up: If you see something, say something.

Manager Obligations: 

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure

• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.

• Model and reinforce a Speak Up culture on your team.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.  The employee may perform other functions that may be assigned.  Management retains the discretion to add or change the duties of this position at any time.

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.