The Manager GVP Auditing and will provide professional expertise, guidance, and leadership for the GVP Audit Program and Audit Team. We expect you to build strategic partnerships and direct risk-based quality auditing activities across Global Development (GCP/GVP/SUB) and/or Preclinical Development (GLP). You will supervise GVP audit team and ensure audits are executed appropriately. You will apply expertise in Good Pharmacovigilance Practice (GVP) and international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with drug development and post-marketing authorization. We expect you should have solid 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 including HIPAA Privacy Rule, and other international and national rules as applicable.
In this role, a typical day might include the following:
Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.)
Assists with the management of resources & staff to accomplish the annual audit schedules.
Provide leadership, mentorship, and supervision to team members and other staff as the need arises.
Liaise with Quality Assurance and cross functional teams to facilitate the adequate closure of audits.
Represent QAA on teams, compliance projects and initiatives both within and across functional areas of Global Development to ensure compliance with related regulations and internal procedures.
Identify training opportunities for current staff.
Assist in the selection, training and leading all aspects of the onboarding of contract auditors.
Lead or provide strong support to audits as needed.
Assist with the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested.
Delegate vital tasks and duties to other functional staff.
May act as a subject matter expert in regulatory facility inspections.
This role might be for you if:
We ask for a Bachelor's degree (Master's degree preferred) with 11+ years of relevant proven experience
9+ years' experience direct audit experience and/or 3+ direct supervisory or leadership experience
We assume excellent interpersonal skills and ability to work with people in 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.
Demonstrated experience in driving Quality into the Clinical Trial Operations processes
Self-motivated and able to work effectively in a dynamic environment with ambiguity
Strong leadership with demonstrated ability to work with senior leaders
Good problem solving, written and verbal communication skills
Ability to effectively manage multiple priorities
Strong track record of project management, partner management, collaboration skills and negotiation of sophisticated situations
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
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Posted 42 minutes ago
Posted 42 minutes ago