Senior Manager GD GCP Auditing
This individual will create strategic partnerships and execute risk-based quality auditing activities across GDQA. The Senior Manager, Auditing applies expertise in GCP, GLP GVP (GxP), CSV and international regulations to the auditing process to independently address a variety of complex GxP compliance issues.
The individual will have an expert knowledge of the FDA and EU regulations and ICH mentorship documents along with any other regulations that may affect drug development and post-authorization safety monitoring. This individual will be assigned 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 requirements of their GxP discipline.
This individual is considered a top subject matter expert who possesses an advanced knowledge of the Global Development Organization. One of the key objectives for the Senior 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.
Job duties may include but are not limited to:
- Responsible for “end to end” audit process which includes
- Schedule, prepare, conduct, report and follow-up on routine and directed audits in support of their GxP discipline as directed and in accordance with Regeneron standard operating procedures and quality policies.
- Audits include internal audits and external audits conducted globally.
- This role may require 30 - 40% travel (both domestic and international)
- Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices both within GDQA and across Regeneron.
- Represent GDQA on high value and complex teams, compliance projects and initiatives both within and across functional areas or other departments as applicable.
- May support clinical studies as study representative to develop and execute risk-based audit programs for assigned studies (GCP).
- Interpret and may assist in developing policies and standards, and evaluate potentially critical problems not covered by policies, standards, and regulations.
- May provide education, mentoring and/or training to GDQA and other relevant Global Development departments
- May participate in regulatory inspections by acting as part of the control and/or inspection room team
- Other duties as deemed relevant
JOB REQUIREMENTS:
- Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience
- 5+ years of direct GCP, GLP, and/or GVP audit experience preferred
- Excellent communication skills and ability to work with people at all levels of the organization and externally.
- Demonstrated skills in taking initiative and working independently
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
- Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
- Strong leadership with demonstrated ability to interface with senior leaders
- Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues
- Ability to effectively manage multiple complex and high value priorities with a sense of urgency
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
- Attention to detail and accuracy of work
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.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.