Senior Director, Global Development Quality Assurance (GLP)

Overview

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 the 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 expected to apply your expert knowledge of the FDA and EU regulations and ICH guidance documents with other regulations affecting drug development.

You will manage the GLP audit function within GDQA. You will partner with other members of the GDQA, identifying trends through metrics to diagnose and remediate systemic quality issues. You will oversee the development, execution and reporting of the overall GxP Audit Program(s) for which you are responsible.

This position will be on-site 4 days/week at our Tarrytown, NY offices. We cannot offer a remote option. If eligible, relocation benefits may be offered.

Responsibilities

• 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 conduct 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 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 the GDQA department.

Qualifications and Experience

• Demonstrated 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 manage multiple priorities with a sense of urgency.
• Strong people and project management, collaboration skills and negotiation of complex situations.
• Educational requirement: Bachelors degree (Masters preferred) with 12+ years of relevant industry experience; minimum 10 years of experience in GLP auditing and/or audit strategy and 6-8 years of 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 Clinical Trial Operations processes.

Additional Information

• Salary Range (annually): $216,100.00 - $360,200.00
• 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 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.
• Please note on-site requirements; many Regeneron roles are on-site. For information about on-site policy and expectations for your location, speak with your recruiter.
• Background checks will be conducted as part of the recruitment process in accordance with applicable law of the country where the position is based.

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