The Manager, GCP Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the GCP Auditing group. This individual will build strategic partnerships and implement risk-based quality auditing activities across GDQA. We feel the Manager should apply their expertise in Good Clinical (GCP) and international regulations to the auditing process to independently address a variety of GCP compliance issues. We believe this Manager will have in-depth 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. We expect you to have an in-depth level of knowledge and experience in conducting multiple audit types (e.g., process, site, vendor, etc.), depending on the requirements of their GCP field. The primary goal for the Manager is to continue to develop and master technical auditing skills with the ability to work with minimal support and supervision and is considered a “go-to” person in their field.
In this role, a typical day might include the following:
- Scheduling, preparing, conducting, reporting and follow-up on routine and directed audits in support of their GCP discipline as directed and in accordance with Regeneron standard operating procedures and quality policies.
- Audits include internal audits and external audits conducted globally.
- May support clinical studies as a strategy representative to build and complete risk-based audit programs for assigned studies (GCP).
- Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations.
This role might be for you if:
- You previously have experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs.
- You can optimally communicate across a global organization to key partners that vary in title and scope.
- You are capable of working autonomously and navigate ambiguous situations
- You have phenomenal project management, customer management, teamwork skills and negotiation of sophisticated situations
To be considered, we are expecting individuals to have a Bachelor’s degree (Master’s degree preferred) with 6+ years of relevant proven experience with 4+ years of direct GCP, GLP or GVP audit experience preferred (Must understand GCP principles).
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.