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As a Manager, Good Clinical Practices Audit Strategy is a key position within Global Development Quality Assurance guiding and leading for management of our Good Clinical Practice Audit Strategy Programs. You will create strategic partnerships and direct risk-based audit activities, supporting and oversight of assigned molecules, clinical studies and audit programs. Applying your GCP knowledge to our strategy process we implement audit risk assessments, develop audit programs, determining audit strategy, support auditors and providing metrics reports.
This may be for you if you:
• Partner to develop risk-based audit planning for assigned molecules and studies as well as vendors and processes.
• Maintain strategic audit programs based on risk indicators from study teams and Global Development.
• Ensure audits are conducted in accordance with the approved audit programs and schedules.
• Maintain relevant core study specific information to assist auditors with audit preparation and conduct.
• Apply audit outcomes to identify quality related trends and communicate compliance risks to the organization.
• Represent on complex compliance projects and initiatives both within and across functional areas or other departments, as applicable.
• May also schedule, prepare, conduct, report and follow-up on audits in support of GCP Audit group as needed.
• Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered.
• May participate in regulatory inspections within the control and/or inspection room team.
• Draft and issue periodic reports to management as requested.
• May provides education and/or training to relevant Global Development departments.
To be considered a Bachelor’s degree with 6+ years of industry experience including 4+ years of direct GCP strategy or audit experience. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Knowledge of the FDA and EU regulations and ICH guidance documents along with regulations affecting drug development. This role may require 10 – 20% travel (both domestic and international). Strong track record of project management, collaborator management and negotiation of complex situations.
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.
Salary Range (annually)