Open Positions: Director, IT Governance
Arvinas is a pharmaceutical company focused on developing new small molecules ‒ known as PROTACs (PROteolysis TArgeting Chimeras) ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. The proprietary PROTAC-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets.
This position is a comprehensive quality and governance role to oversee activities in Information Technology and in broader Quality initiatives in the company. It will be based in Information Technology but will have a matrixed reporting structure for its close in
Arvinas is seeking a Director, IT Governance to manage and oversee GxP validation activities, SOX compliance activities, and the overall governance, risk, and compliance process within Information Technology. The Director, IT Governance promotes awareness of business, technology, and information risks, issues, and opportunities. This role partners with business and technology owners to implement and enforce sound processes and practices, risk-informed decision-making, effective risk mitigation, accountability, and compliance with laws, mandates, and policies. This position works closely with the Vice President, Information Technology, and is responsible for the validation of applicable Information Technology systems, drafting, communication, and compliance with Information Technology procedures and policies, and GxP/SOX reporting and compliance activities. The Director will liaise with auditors, both internal and external, to maintain and implement required controls.
This position reports to the VP, Information Technology and will be located at our headquarters in New Haven, CT.
General Roles and Responsibilities
- Establishes and refines corporate computer system validation procedures, organization, and oversight to ensure adherence to respective regulation, especially 21 CFR Part 11.
- Identifies, defines, and leads implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across regulated GxP and SOX areas.
- Ensures computer systems validation is complete.
- Organizes internal investigations and assures complete and accurate documentation (i.e., root cause analysis, CAPAs, etc.).
- Oversees the IT change control process (change control documentation, draft and execution of test plan, implementation of change in production).
- Promotes quality best practices among staff.
- Maintains functional requirements for all GxP quality systems.
- Develops and revises procedures as needed; assists with development and promotion of policies.
- Develops, implements, and leads a governance and risk strategy and process to monitor and evaluate business, technology, and information risks and issues.
- Integrates information from business and technology process, security and compliance audits and investigations into risk management strategy.
- Ensures risk management priorities are reflected in strategic plans and initiatives.
- Measures and reports on effectiveness of strategies, policies, and procedures for managing risks.
- Advises and collaborates with stakeholders on identifying, assessing, and mitigating risks and control weaknesses.
- Manages compliance with privacy and information safeguarding requirements.
- Maintains inventory of mandated reporting and monitoring.
- Oversees internal and external reviews, audits, inspections, and investigations.
- Proposes new or updated policies and procedures to promote compliance.
- Maintains and annually reviews policies, procedures, and standards.
- Manages IT controlled documents and liaises with functional area leads to identify and design document management procedures that are compliant and integrated into organizational electronic document management systems (eDMSs).
- Oversees IT training plans, including establishment of training curriculum, assignment, records management, and compliance monitoring and reporting.
- Assists with selection of quality systems.
- Provides consultation/expertise on complex projects and other IT activities.
- Performs other duties as assigned.
Knowledge, Skills, and Abilities:
- Advanced knowledge in computer systems and technologies, project management principles, applicable laws and regulations as they relate to IT, business management/theory/processes, budgeting. Proven leadership ability, excellent communication skills (verbal and written), excellent interpersonal skills, superior analytical and problem solving skills, demonstrated ability to apply IT in solving business problems, strong negotiation skills, strong presentation skills, keen attention to detail, exceptionally self-motivated and directed with a service orientation.
- Solid understanding of quality management and continuous process improvement principles.
- Thorough understanding of GxP regulations, guidances, and principles, including of 21 CFR Part 11.
- Knowledge of SOX Information Technology General Controls (ITGCs).
- Knowledge of the System Development Lifecycle (SDLC) and thorough understanding of the Quality role in that process.
- Bachelor’s degree in Biology, Chemistry, Engineering or related scientific discipline required; Advanced degree (MS, PhD, MBA) preferred.
- Minimum of ten years of related experience is required.
- 5-8 years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a GxP role.
- Experience in developing and managing the implementation of formal testing methodologies.
- Experience with GxP and SOX audits, including working directly with internal and external auditors.
- Must have experience with electronic document management and quality systems.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.