As a Senior Director, Global Development Quality Assurance (GDQA) you will provide leadership for an entire GLP function. You will lead all staff while developing and leading all aspects of the execution of functional/departmental mission and vision. You will create and oversee strategic partnerships and implement risk-based quality auditing activities internally and with external organizations. You are expect to apply your expert knowledge of the FDA and EU regulations and ICH guidance documents with other regulations affecting drug development.
You will manage Good Laboratory (GLP) audit function within GDQA. In addition, we partner with other members of the GDQA, identifying trends through metrics to diagnose and remediate systemic quality issues. We oversee the development, execution and reporting of the overall GxP Audit Program(s) for which they are responsible.
This position will be on-site 4 days/week at our Tarrytown, NY offices. We cannot offer a remote option. If eligible, we can offer relocation benefits.
A typical day may include the following:
• Developing and managing the overall strategic plan for the GLP audit functions.
• Represent the GDQA audit function by providing audit and compliance input in cross functional meetings and external meetings.
• Manage, hire and develop direct reports within GDQA and conducting Mid-year and End-of year performance assessments.
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices.
• Represent GDQA on top priority teams, complex compliance projects and initiatives both within and across functional areas or other departments as applicable.
• Be responsible for policies, standards, and regulations, and evaluate potentially critical problems.
• Oversee the education and/or training of the GDQA organization and other Global Development departments as needed.
• Ensure succession planning and business continuity for GDQA department.
This may be for you if you:
• Can demonstrate success in leading a GLP Quality Assurance (GDQA) function.
• Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
• Ability to effectively manage multiple priorities with a sense of urgency
• Strong people and project management, collaboration skills and negotiation of complex situations
To be considered a Bachelor’s degree (Master’s preferred) with 12+ years of relevant industry experience is required. We are seeking a minimum of 10 years’ experience working in GLP auditing and/or audit strategy and 6-8 years prior supervisory/leadership experience. Strong knowledge of FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs is necessary. Demonstrated experience in driving Quality into the Clinical Trial Operations processes.
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)
Skills Required
- Bachelor's degree (Master's preferred)
- 12+ years of relevant industry experience
- 10 years' experience working in GLP auditing and/or audit strategy
- 6-8 years prior supervisory/leadership experience
- Strong knowledge of FDA or other Regulatory Inspections
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.
Regeneron Insights
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.
