As a Director of IT, Quality Assurance and Compliance you will lead and manage a team, consisting of 20 to 30 members, including direct reports. The focus of this role is to provide leadership, coaching, and technical support to the Corporate IT QA & Compliance Management Team, the supporting IT and business functions, and Managed Service Providers. We provide regulatory compliance support and services continuing to advance the principles of regulatory compliance throughout the IT organization.
This is an on-site position for 4 days/week at our Sleepy Hollow, NY or Basking Ridge, NJ office with 1 day/week working from home. If eligible, we can offer relocation benefits. We cannot offer a fully remote option.
A typical day may include the following:
Collaborate with Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices.
Oversee the preparation and management of our Health Authority and internal company audits. Ensures all IT-related aspects are compliant and audit-ready.
Facilitate risk analysis and process modeling white-board sessions with direct reports team to develop cross-functional support processes.
Define the approach and provide oversight for the Corp. IT GxP Training efforts.
Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, across all our IT systems and processes.
Ensure policies, procedures, and best practices to maintain the highest standards of compliance.
Provide strategic direction and leadership fostering a culture of continuous improvement and excellence.
Ensure timely and effective communication with all collaborators, including senior management, regulatory authorities, and cross-functional teams.
Monitor and assess the impact of new regulations and guidelines and implement needed changes to maintain compliance.
Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) models.
Manage the budget and resources, ensuring efficient and effective use of resources.
Oversee IT quality incident investigations, including input and approval of plans for resolution of issues. Partner with collaborators to ensure CAPAs are appropriate and effective.
Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.
This may be for you if you:
• Want to be entrusted to support all IT compliance aspects of our science from conceptualization through manufacturing.
• Possess experiences to inspire others within your organization
• Have worked in a rapid response environment.
• Ability to think strategically and drive continuous improvement initiatives.
• Strong problem-solving skills ensuring sound decisions under pressure.
• Meticulous with a solid focus on quality and compliance.
To be considered for this role, you must have: Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field along with 12+ years of experience in IT quality assurance and compliance within the biopharmaceutical industry. An advanced degree is preferred. Strong leadership and management skills, with experience in leading and developing high-performing teams. Strong communication and presentation skills.
Additional requirements:
• Extensive knowledge of GxP regulations, including GMP, GCP, and GLP
• Managing IT responsibilities for Health Authority and internal company audits. The ability to review, assess and defend critical audit observations where applicable.
• Ability to train staff in accordance with regulatory and company standards is critical.
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)
$180,400.00 - $300,700.00
Regeneron Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Regeneron and has not been reviewed or approved by Regeneron.
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Healthcare Strength — Medical, dental, and vision coverage is positioned as comprehensive, with Regeneron prescription drugs covered at 100% for those enrolled in the medical plan. Mental health support is also emphasized through EAP access and tools like Talkspace and the Journey app.
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Equity Value & Accessibility — Stock grants are described as available to all employees, strengthening the overall total-rewards package beyond base pay. Long-term incentives and stock-related rewards are repeatedly framed as meaningful components of compensation.
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Parental & Family Support — Paid parental leave is paired with fertility/adoption assistance and childcare-related support such as discounts and nanny services. Additional family-oriented resources extend to elder care, pet care, and education support like college coaching and tutoring.
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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. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
