Senior Manager, GVP Auditing

The Regeneron Senior Manager, GVP Auditing, is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the Good Pharmacovigilance (GVP) audit function. We believe this Sr. Manager will create strategic partnerships and implement risk-based quality auditing activities across the Regeneron Pharmacovigilance System. We Senior Manager applies expertise in GVP, GxP and international regulations to the auditing process to independently address a variety of complex GxP compliance issues. The GVP Auditor will have an expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and post-authorization safety monitoring. We expect the Auditor to be assigned to lead audits of higher complexity (e.g., directed audits) and is expected to have a deeper level of knowledge and experience in conducting all audit types (e.g., process, vendor, license partner, etc.). The Sr. Manager is considered a top subject matter expert who possesses an advanced knowledge of the Drug Development space. One of the key objectives for the Auditor is to support the development and execution of departmental goals and objectives and to assist with the training and mentoring of audit staff.

In this role, a typical day might include the following:

• Responsible for “end to end” audit process which includes
• Schedule, prepare, conduct, report and follow-up on routine and directed audits in support of their GxP discipline as directed and in accordance with Regeneron standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally.
• Own the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and standard processes both within GDQA and across Regeneron.
• Represent GDQA on high value and complex teams, compliance projects and initiatives both within and across functional areas or other departments as applicable.

This role might be for you if:

• You previously experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs.
• You can effectively communicate across a global organization to key partners that vary in title and scope.
• You are capable of working autonomously and navigate ambiguous situations
• You have phenomenal project management, customer management, teamwork skills and negotiation of complex situations

To be considered, we are expecting individuals to have a Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience with 5+ years of direct GVP audit experience preferred.