Senior Manager, Global Development Quality Assurance (GCP)

The Regeneron Senior Manager, Global Development Quality Assurance, is a key position in the supervising, guiding and leading for one of the Good Clinical Practice (GCP) audit programs. Responsibilities include managing direct reports while supporting the development and execution of departmental mission, vision and goals. As part of the role of people manager, you will be responsible for staff development & training and resourcing direct reports. You will create strategic partnerships and implement risk-based quality auditing activities. 
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
This is a United States based remote position. This role may require 20 – 30% travel (both domestic and international). 

Discover your role:
•    Manage, hire and develop direct reports by meeting with direct reports at least monthly and conducting performance assessments. 
•    Responsible for the training, resourcing, and individual staff development. 
•    Schedule, prepare, conduct, report, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with our standard operating procedures and quality policies. 
•    Audits include internal audits and external audits conducted globally. 
•    Represent the department by providing audit and compliance input in cross functional meetings 
•    Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices. . 
•    Interpret and may assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations. 
•    Provides education and/or training to GDQA and other relevant Global Development departments. 
•    May participate in regulatory inspections by acting as part of the control and/or inspection room team 

This role requires:

As Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience Deep knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and/or post-authorization safety monitoring is required. 5+ years of both direct people management and GCP audit experience preferred Excellent communication and people management skills and ability to work with people in all levels of the organization and externally. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. 
•    Strong leadership with demonstrated ability to collaborate with both direct reports and senior leaders 
•    Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues. 
•    Strong track record of project management, partner management, collaboration skills and negotiation of complex situations 
 

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)