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Open Positions: Director, IT Quality and Regulatory Systems

Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.

#TeamArvinas is made up of more than 350 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.

Position Summary

Arvinas is seeking a Director, IT Quality and Regulatory Systems to manage and scale the systems infrastructure and roadmap for those teams. This individual will work closely with Arvinas’ Quality and Regulatory groups to gain a deep understanding of the Quality Affairs, Regulatory Affairs, and Regulatory Operations functions.

This role will define short and long-term plans of business area needs (including related priorities and budgets), development of business processes and as well as support selection, implementation, and administration of related Quality and Regulatory solutions. This person will also advise the Quality and Regulatory teams regarding industry best practices, systems, and solutions to improve efficiency and effectiveness, and will partner with the Senior Director, IT R&D and Clinical Systems on GxP impact and considerations in those respective areas.

The individual must have a proven ability to:

  • Lead significant projects,
  • Deliver high-quality Quality and Regulatory systems, and
  • Work with the teams to design a technology roadmap of the Quality and Regulatory systems for the next 3-5 years.

This position reports to the Vice President, Information Technology & Corporate Projects and can be remote, hybrid or located at our headquarters in New Haven, CT.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

Leadership:

  • Build and lead the divisional IT Quality and Regulatory Systems vertical, providing guidance, management, and direction for a future team of capability managers and system administrators (staffed as necessary from system count and complexity).
  • Develop and implement policies, controls, and processes in compliance with regulatory requirements.
  • Provide technical leadership and guidance for the Quality and Regulatory teams at Arvinas.
  • Partner with the Senior Director, IT Governance, to provide clear direction for GxP management of IT processes and systems.
  • Partner with the Senior Director, IT R&D and Clinical Systems on developing and supporting technologies and processes for the seamless and GxP-compliant flow of Clinical data and documents into Regulatory systems and processes.
  • Act as vendor manager for Quality and Regulatory systems, software, and support.

Projects and Systems:

  • Manage Request for Proposal (RFP) process including documenting requirements, identifying and engaging vendors, following product selection processes, overseeing contracting and negotiations, and managing product vendors.
  • Ensure system lifecycle management practices are followed and anticipate and plan the upgrade and obsolescence pathways.
  • Develop Tier 1-3 support plans for Quality and Regulatory systems and software with consideration for integration with broader Arvinas IT support methodology.
  • Partner with the individual Quality and Regulatory teams to continually assess 3rd-party support services and migrate to the internal IT team when necessary.
  • Ensure oversight of existing systems landscape and provide architectural guidance for upstream and downstream data flow across systems.
  • Design solutions using custom or existing systems to meet the needs of the Quality and Regulatory teams.
  • Prepare detailed systems roadmaps that define integration points and data strategy.
  • Identify new technologies and solutions for process improvement.
  • Assemble and guide technical project teams, serve as project lead on Quality and Regulatory technical projects, and drive the implementation of agreed IT/Quality/Regulatory initiatives.
  • Ensure cohesive implementation and data integrity across Quality and Regulatory system platforms and databases.
  • Partner with the Senior Director, IT Governance, Senior Director, IT R&D and Clinical Systems, and Quality department where necessary to provide hands-on assistance with implementing and maintaining GxP systems.
  • In partnership with IT Infrastructure and Security, developing and coordinating patching/maintenance approaches for Quality and Regulatory systems infrastructure, ensuring operations windows do not interrupt Quality and Regulatory team activities, and ensuring systems and processes are compliant with Security practices.
  • Recommend, implement and maintain collaboration solutions with Quality and Regulatory Vendors, contractors, CRO’s and other external partners.

Other Responsibilities:

  • Oversee the IT change control process (change control documentation, draft and execution of test plan, implementation of change in production) for Quality and Regulatory systems.
  • Drive annual IT-related business initiative road mapping exercises.
  • Coordinate global discussions and alignments on Quality and Regulatory GxP technology strategy, platforms, enhancements where applicable.
  • Manage and prioritize a portfolio of related initiatives.
  • Partner with business process owners and technology partners to elicit, analyze, translate, and document business processes.
  • Develop budgets, plans, and project manage implementations of appropriate solutions to ensure that projects are delivered on time and within budget and meet business need.
  • Work in concert with the user community to actively manage change and optimize solutions through their lifecycle.
  • Support systems validation/testing to GxP compliance.
  • Enhance solutions to insure optimum utilization of resources and GxP compliance.
  • Provide guidance and advisory services in the areas of industry best practices as well as systems and solutions to improve effectiveness and efficiency.
  • Identify, define, and lead implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across Quality and Regulatory areas.
  • Maintain functional requirements for all Quality and Regulatory systems.
  • Integrate information from business and technology process, security, and compliance audits and investigations into risk management strategy.
  • In partnership with IT Governance, ensure risk management priorities are reflected in strategic plans and initiatives.
  • Advise and collaborate with stakeholders on identifying, assessing, and mitigating risks and control weaknesses.
  • Maintain inventory of mandated Quality and Regulatory system reporting and monitoring.
  • Oversee internal and external reviews, audits, inspections, and investigations related to Quality and Regulatory systems.
  • Maintain and annually review policies, procedures, and standards related to Quality and Regulatory systems.
  • Collaborate with Quality on GxP systems training plans, including their establishment of training curriculum, assignment, records management, and compliance monitoring and reporting.
  • Provide consultation/expertise on complex projects and other IT activities.
  • Perform other duties as assigned.

Qualifications

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 the System Development Lifecycle (SDLC) and thorough understanding of the Quality role in that process.
  • Knowledge of Regulatory publishing standards is preferred.
  • Familiarity with ICH and GDPR is preferred.

Experience:

  • Minimum of ten years of related experience is required.
  • 12-15 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 audits, including working directly with internal and external auditors.
  • Must have experience with electronic document management and quality systems.
  • Specific experience implementing and supporting Quality and Regulatory systems is preferred (e.g., QMS, document management, submissions management and publishing, etc.)
  • SharePoint management experience is preferred.

Education

  • Bachelor’s degree is preferred; Advanced degree (MS, PhD, MBA) is a plus.

#LI-Remote

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

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