As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team.
This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option.
A typical day may include the following:
Collaborate with our Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices.
Lead all aspects of the preparation and management of our Health Authority, agency and internal company audits. Ensure all IT-related aspects are in compliance and audit-ready.
Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, SOX, and other compliance requirements, across all our IT systems and processes.
Ensure policies, procedures, and practices maintain the highest standards of compliance.
Define the approach and provide oversight for the Corp. IT GxP Training efforts.
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 solutions to maintain compliance.
Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) models.
Establish the framework to ensure non GxP systems adhere to documentation standards and manage the evaluation of tools to support system testing.
Oversee 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.
Lead and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.
This may be for if you:
Have the ability to review, assess and defend critical audit observations where applicable.
Can demonstrate success stablishing and maintaining strong long-term relationships, communications with Executives, Managers, and Subject Matter Experts in both IT and business unit groups.
Demonstrated ability to provide influence and work effectively with individuals at all levels of the organization, including senior leadership.
To be considered you are to have a Bachelors degree with 10+ years of experience in Information Technology which should include resource management experience, leading vendors and partners and project budget management. Ability to train staff in accordance with regulatory and company policies is critical. Can demonstrate extensive knowledge of GxP regulations, including GMP, GCP, and GLP. Experience practicing a range of project prioritization and resource management methods. Proven track record to innovate and drive framework, tools, templates and change in a cross-functional matrixed organization. Excellent communication/presentation skills (written/verbal). A Master's degree and/or a Project Management Professional (PMP) certification is preferred.
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)
$212,900.00 - $354,800.00