Senior Director, Global Development Quality Assurance (GLP)

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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$216,100.00 - $360,200.00