Senior Manager, Global Development Quality Assurance (GCP)

Regeneron Pharmaceuticals

45d•$134,400 - $219,200•Remote

About The Position

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.

Requirements

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.
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

Nice To Haves

5+ years of both direct people management and GCP audit experience preferred

Responsibilities

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