Director PV Auditing

Location
Basking Ridge, NJ, United States
Posted
May 28, 2021
Ref
25086BR
Required Education
Bachelors Degree
Position Type
Full time

The Regeneron Director QA (PV) Auditing is a key position in the Quality Assurance and Auditing (QAA) group and will provide professional expertise, guidance, and leadership for the GVP Audit Program. This individual will create strategic partnerships and direct risk-based quality auditing activities across Global Development (GCP/GVP/SUB) and/or Preclinical Development (GLP). S/he will partner with other members of the GCP Quality department, PV management, and Preclinical management to identify trends through metrics in order to diagnose and remediate systemic quality issues.
In this role, a typical day might include the following:

  • Responsible for developing and managing the overall strategic plan for the GVP audit function and programs.
  • Represent the QAA audit function, providing audit and compliance input in cross functional meetings.
  • Manages resources & staff to accomplish the annual audit schedules.
  • Provide leadership, guidance, supervision, and develop direct reports.
  • Assess and prioritize both internal and external audit needs.
  • 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 Preclinical and Global Development to ensure compliance with related regulations and internal procedures.
  • Drafts and issues periodic area metrics reports to management, cross functional groups and leadership teams as requested.
  • Raise critical compliance issues to appropriate management to ensure mitigation and remediation.
  • Subject matter expert in regulatory facility inspections.
  • Ensure succession planning and business continuity for the function.

This role might be for you if you have:

Excellent communication skills and ability to work with people in all levels of the organization and externally.

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 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

Ability to effectively manage multiple 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

We require a Bachelor's degree (Master's degree preferred) with 12+ years of relevant industry experience. We also require 10+ years' experience working in GVP auditing and 6+ years prior supervisory/leadership experience.
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.