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
Didn't find what you're looking for? Search again!
Loading more jobs...