The Associate Director, CSV Auditing in the Global Development Quality Assurance (GDQA) will provide supervision, guidance and leadership for the Computer System Validation (CSV) Audit Programs. You will create strategic partnerships, directing risk-based quality auditing activities. Additional responsibilities for GCP, GLP, and/or GVP audit teams ensuring audits are implemented.
A typical day may include the following:
• Lead/support the development and execution of departmental goals and objectives ensuring top talent is developed and maintained while acting as a mentor and training new staff.
• Develop standards and audit methods to keep current with new technologies and advancement within clinical development to support the “end to end” audit process.
• Scheduling, preparing, conducting, reporting and follow-up on routine and directed audits supporting GxP subject areas in accordance with our standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally.
• Participate 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 ensuring compliance with related regulations and internal procedures.
• Provide training and mentoring to GDQA personnel and relevant departments.
• Participate in the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams
• May assist in the conduct and act as a subject matter expert in regulatory inspections.
To be considered it is required to have a Bachelor’s degree (Master’s degree preferred) with 11+ years of relevant experience including 9 years auditing with CSV and 3 years management experience. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. 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 role may require 30 – 40% travel (both domestic and international)
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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