Director, Inspection Management
This position reports to the head of, GCP Quality, Inspection Management. This will be a hands-on leader responsible for organization in planning, preparing and conducting GCP/GPV inspections by regulatory authorities (e.g. FDA, EMA, PMDA).
This will include, but not limited to, inspection readiness activities (e.g. start-up and gap assessments), inspection management training, developing and maintaining Regeneron's inspection management process and development of inspection management tools and systems. The expectation is that Global Development will remain inspection ready at all times.
In this role, a typical day might include the following:
You will maintain a consistent process for inspection readiness and management across clinical projects and lead GCP inspection readiness meetings, attend functional department meetings and Study Management team meetings to ensure expectations are communicated in a timely manner.
Run regulatory inspections (onsite or remote) including inspection responses, commitments, post-inspection activities. Work with the Inspection team in the EU to ensure collaborative and efficient practice and processes. Collaborate with Clinical Study team members to ensure that inspection preparation requirements are met per required timelines.
Prepare Inspection Management Plans that include activities to build inspection readiness into the development process. Co-lead/Lead all communications and inspection preparation training for vendors and sites. Identify gaps and issues and work with team(s) to build strategies to mitigate risks during inspections.
Conduct inspection preparation sessions (mock interviews/inspections, training, preparation visits). Assist the Clinical and Quality Auditing teams in preparation, conduct and tracking of issues for Site Inspection Readiness.
Lead the "ready room" for GCP and Post Marketing Surveillance inspections
Communicate lessons learned/best practices within GD in collaboration with the Training group within Global Clinical Development (GCD). Provide expeditious inspection updates/daily summaries to GD Management, and appropriate internal and external partners during regulatory inspections. Ensure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all concerns for timely closure.
This role might be for you if:
Bachelors or Master's degree with at least 10+ years of relevant experience.
5+ years of regulatory compliance experience and managing regulatory inspections within GCP.
Knowledge and experience with regulatory authority inspection practices internally, externally, domestic and internationally. Extensive experience leading and supporting regulatory authority inspections of clinical research activities-Direct interaction with inspectors required.
Detailed knowledge and application of international requirements of GCP and ICH Guidelines. Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials. Strong proven understanding of clinical development and operations. Experience in providing training on key quality and regulatory compliance information.
Excellent verbal, written communication and presentation skills with an ability to collaborate with senior leaders and cross-functional teams
Experience with supporting GPV regulatory inspections preferred
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
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 outstanding benefits including health and wellness programs, fitness centers and stock for all employees!
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.