As an Associate Director, Global Development Quality Assurance, you will play a key role supervising, guiding and leading our Good Clinical Practice (GCP) Audit Programs. Responsibilities include managing direct reports, supporting the development and execution of departmental goals and objectives. We also create strategic partnerships and oversee risk-based quality auditing activities. You will also apply your knowledge of the FDA and EU regulations and ICH guidance documents with other regulations that may affect drug development and post-authorization safety monitoring.
A typical day include the following:
• Manage, hire and develop direct reports at least monthly and conducting Mid-year and End-of year performance assessments.
• Responsible for the training, resourcing, and individual staff development of direct reports.
• Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices.
• Represent the GDQA audit function by providing audit and compliance input in cross functional meetings.
• Represent GDQA on high-priority and highly visible teams, compliance projects and initiatives both within and across functional areas or other departments as applicable.
• Assist managing staff resourcing (internal & external) to accomplish the annual audit schedules.
• Assist assessing and prioritization of both internal and external audit needs.
• Assist with the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested.
• Interpret and may assist in developing policies, standards, and regulations, and evaluates potentially critical problems.
• Responsible for “end to end” audit process which includes:
• Scheduling, preparing, conducting, reporting, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with Regeneron standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally
• Provide education and/or training to GDQA staff and other relevant Global Development departments.
• May participate in regulatory inspections by acting as part of the control and/or inspection room team
• This role may require 20 – 30% travel (both domestic and international)
This may be for you if you:
• Demonstrated skills in taking initiative and working independently
• Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
• Ability to effectively manage multiple complex priorities and direct reports
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
To be considered a Bachelor’s degree (Master’s degree preferred) with 11+ years of relevant industry experience including 9+ years of direct people management and/or GCP audit experience preferred. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues.
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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