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 an Associate Director, IT Governance to assist in executing Arvinas technology governance,  IT GxP validation activities, SOX compliance activities, and the compliance processes within Information Technology.  This role partners with business and technology owners to guide technology governance, in accordance to the Information Systems LifeCycle (ISLC) and in compliance with laws, mandates, and policies.  This position is responsible for IT oversight and validation execution for applicable GxP Information Technology systems; drafting of and adherence to, Information Technology procedures and policies; and SOX IT General controls and compliance activities.  The Associate Director may liaise with both internal and external auditors.

This position reports to the Senior Director, IT Governance and is located in New Haven, CT or can be based in a remote work location in the United States.

Principal Responsibilities

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

  • 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 per applicable procedures.
  • Ensures compliance with Information Systems LifeCycle for technology projects. 
  • Establishes and maintains a SOC report review process within IT. 
  • Acts as Test Lead for IT System implementations, as needed.  
  • Reviews and approves ISLC deliverables as IT Governance.
  • Conducts internal monthly IT audits for critical processes such as onboarding / offboarding.  
  • Oversees the IT change management process.
  • Develops and revises procedures as needed; assists with development and promotion of policies.
  • Oversees the periodic review process for IT policies and procedures. 
  • Advises and collaborates with stakeholders on identifying, assessing, and mitigating risks and control weaknesses.
  • Participates in internal and external reviews, audits, inspections, and investigations.
  • Oversees IT training plans, including establishment of training curriculum, assignment, records management, and compliance monitoring and reporting.
  • Performs other duties as assigned.

Qualifications

  • Minimum of 10-15 years of related IT 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 in computer system validation, system testing, or quality oversight role.
  • Thorough understanding of GxP regulations, guidance's, and principles, including of 21 CFR Part 11.
  • Knowledge of SOX Information Technology General Controls (ITGCs).
  • 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.

Education

  • Bachelor’s degree in IT, Science, Engineering or related scientific discipline required; Advanced degree (MS, PhD, MBA) preferred.

 

#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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