We are currently looking to fill a Associate 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 software
To be considered for this role you must hold a Bachelor’s degree in Life Sciences and 8+ years relevant experience in an FDA regulated industry and at least 5 years’ experience in a managerial role.
May substitute proven experience for education requirement.
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$145,600.00 - $237,600.00
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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