Senior Manager GD GCP Auditing

The Regeneron Senior Manager, Auditing, is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance (GVP) and Computer System Validation (CSV) audit functions. This individual will create strategic partnerships and execute risk-based quality auditing activities across GDQA. The Senior Manager, Auditing applies expertise in GCP, GLP GVP (GxP), CSV and international regulations to the auditing process to independently address a variety of complex GxP compliance issues. The individual will have an expert knowledge of the FDA and EU regulations and ICH mentorship documents along with any other regulations that may affect drug development and post-authorization safety monitoring. This individual will 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, site, vendor, license partner, etc.), depending on the requirements of their GxP discipline. This individual is considered a top subject matter expert who possesses an advanced knowledge of the Global Development Organization. One of the key objectives for the Senior Manager, Auditing, is to support the development and execution of departmental goals and objectives and to assist with the training and mentoring of audit staff. Job duties may include but are not limited to:

• 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.
• This role may require 30 - 40% travel (both domestic and international)
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices 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.
• May support clinical studies as study representative to develop and execute risk-based audit programs for assigned studies (GCP).
• Interpret and may assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
• May provide education, mentoring 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
• Other duties as deemed relevant
  
  Bachelor's degree (Master's degree preferred) with 8+ years of relevant industry experience
• 5+ years of direct GCP, GLP, and/or GVP audit 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 leaders
• Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues
• 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
• Attention to detail and accuracy of work