Functieomschrijving
This position manages a team responsible for the day-to-day maintenance, support, and development of Regeneron's IT Applications portfolio, including but not limited to Empower CDS, SDMS, and other business supporting applications. Responsible for managing the application portfolio and associated support staff, driving audit readiness and compliance, and ensuring systems are maintained in a validated and compliant state — with particular emphasis on data integrity and 21 CFR Part 11 requirements. The role contributes to the strategic direction of the IOPS IT Applications function and collaborates closely with peer managers overseeing complementary application portfolios.
As an IT Applications Manager, a typical day might include the following:
- Manages a team of FTEs responsible for supporting and maintaining IT Applications, encompassing performance management, mentoring, coaching, and staff development.
- Works with staff in the development of annual goals; performs monthly performance reviews and develops annual performance evaluations.
- Works in close collaboration with peer managers overseeing different application portfolios to ensure alignment, shared best practices, and coordinated delivery across the broader IOPS IT Applications function.
- Collaborates with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner.
- Drives audit readiness across the application portfolio; serves as a key point of contact during FDA inspections and internal audits, ensuring systems, audit trails, and documentation are inspection-ready at all times.
- Ensures all supported applications are maintained in a compliant and validated state; proactively identifies and resolves data integrity and compliance issues in accordance with 21 CFR Part 11, applicable DI principles, SOPs, and policies.
- Maintains responsibility for the accuracy of system documentation, including User Requirement Specifications, Design Specifications, Configuration Specifications, Test Plans, for validated systems.
- Manages relationships with vendors, including vendor performance, contract adherence, and ensuring delivery of services in line with business and regulatory compliance requirements.
- Develops and implements operational rigor using metrics and other operational controls; drives continuous improvement initiatives that enhance workflows, system reliability, and team efficiency.
- Contributes to and supports the strategic vision and direction of the IOPS IT Applications function in collaboration with key stakeholders, including IT leadership, QA, and business units.
This role may be for you if you:
- Recognize the importance of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production, should display a high level of integrity in the performance of his/her work.
- Passionate about quality / right first time.
- Proven ability to support Applications in a highly regulated environment.
- Knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11.
- Knowledge of Regulatory Asset Manager Systems advantageous.
- Excellent written and oral communication skills.
- Possess excellent customer facing skills allowing comfortable traversing of cross departmental levels
In order to be considered for this position, you must hold a Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field and
- Manager: 7+ years of experience, 3+ years of managing teams.
- GMP Laboratory/IT setting preferred.
- Senior Manager: 8+ years of experience, 4+ years of managing teams.
- GMP Laboratory/IT setting preferred.
- May consider experience in lieu of education. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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)