Sr Director, IT Quality

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: May 6, 2022

Job Description:

We are currently looking to fill a Sr Director IT Quality position. This position will be responsible for providing leadership and functional oversight for quality operations supporting IT and IS globally at Regeneron's facilities.In this role, a typical day might include the following:

• Develop and maintain an industry leading approach to computer systems validation.
• Lead the development of processes and systems that drive compliance to critical regulatory requirements specific to IT systems, including enterprise systems.
• Responsible for leading and maintaining a comprehensive data integrity approach.
• Collaborate with management to ensure understanding and acceptance of the roles and responsibilities of the organizations supporting information technologies and systems.
• Promote a GXP and quality mentality across the organization.
• Ensure appropriate execution of validation strategies and compliance with internal procedures.
• Maintain the visibility of any noted deviations or deficiencies through trend and root cause analysis; and coordinate with the appropriate teams and functions to implement robust CAPAs.
• Ensure that all quality results associated with IT and IS comply with regulatory and quality policies and procedures.
• Participates in FDA and other regulatory inspections and leads presentation strategy development for CSV and QA IT related topics.
• Keep current on regulatory requirements and work with other functions to incorporate into Regeneron systems.
• Interviews, hires, orients, and trains incoming personnel.
• Lead staff as assigned to work with project teams on their quality projects.
• Ensure direct-report staff is appropriately resourced, supported and has the tools and direction to accurately complete their team's objectives.
• Coaches, develops and mentors team members.This role might be for you if you:
  • Are able to influence others to achieve results and to challenge the status quo
  • Excel in a quality driven organization
  • Have prior experience in a Quality Assurance and/or IT organization
  • Have experience leading the implementation of quality systems softwareTo be considered for this role you must hold a Bachelor's degree in Life Sciences with 15+ years of relevant experience in an FDA regulated industry, with at least 8 years in management. May substitute proven experience for education requirement.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Troy , Sr Director, IT Quality, Executive , Troy, New York