The Manager, QA-CSV (Quality Assurance - Computer System Validation) Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the CSV Auditing group. This individual will build strategic partnerships and implement risk-based quality auditing activities across GDQA. We feel the Manager, CSV Auditing, should apply their expertise in GxP, CSV and international regulations to the auditing process to independently address a variety of CSV compliance issues. We believe the person in this role 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 the person in this role 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 GxP requirements.
The individual in this role is considered a top subject matter expert who possesses an advanced knowledge of the Global Development Organization. One of the key objectives for the 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.
In this role, a typical day might include the following:
Scheduling, preparing, conducting, reporting and follow-up on routine and directed CSV audits in in accordance with Regeneron standard operating procedures and quality policies.
Audits include internal audits and external audits conducted globally.
Support other GxP (GCP, GLP, GVP) audits as a CSV SME.
Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations.
Guide and train team members.
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 for this role, 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 CSV/IT audit experience preferred (Must understand GxP regulations/principles).
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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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