Associate Director GD GCP Auditing

The Regeneron Associate Director, Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide supervision, guidance and leadership for the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and Computer System Validation (CSV) Audit Programs. Additionally, this individual will oversee GCP, GLP, and/or GVP audit teams and ensure audits are executed appropriately. The Assoc. Director, Auditing applies expertise in GxPs, CSV and international regulations and guidelines to the auditing process to independently address a variety of highly complex compliance issues. The individual 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. This individual will be an expert on all audit types with a focus on developing new standards and audit methods in order to keep current with new technologies and advancement within clinical development. One of the key objectives for the Associate Director, Auditing, is to lead/support the development and execution of departmental goals and objectives and to help ensure that top talent is developed and maintained within GDQA while acting as a mentor and trainer for new staff. Job duties may include but are not limited to:

• Support the "end to end" audit process which includes:
• Scheduling, preparing, conducting, reporting 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.
• This role may require 30 - 40% travel (both domestic and international)
• Assist with the management of GDQA resources to accomplish the annual audit schedules.
• Provide leadership, guidance, and supervision to staff as required.
• Assist with the assessment and prioritization of both internal and external audit needs.
• Represent GDQA on high priority and highly visible teams, compliance projects and initiatives both within and across functional areas of Global Development to ensure compliance with related regulations and internal procedures.
• Provide training and mentoring to GDQA personnel and relevant Global Development departments.
• Assist with the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested.
• May assist in the conduct and act as a subject matter expert in regulatory inspections.
• Other duties as deemed relevant
  
  Bachelor's degree (Master's degree preferred) with 11+ years of relevant industry experience
• Combination of 9+ years' experience of direct audit and/or industry experience preferred
• Excellent communication skills and ability to work with people at all levels of the organization and externally.
• Demonstrated skills in taking initiative and working independently
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
• Strong leadership with demonstrated ability to interface with senior/executive leaders
• Excellent problem solving, written and verbal communication skills
• Ability to effectively manage multiple complex and high value priorities with a sense of urgency
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
• Identifies opportunities to initiate operational changes and policy modifications within discipline
• Attention to detail and accuracy of work