Associate Director, Inspection Management
We are currently looking to fill a Sr Manager or Associate Director of Inspection Management position. This position will provide support during regulatory inspections and internal audits. This individual will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.
In this role, a typical day might include the following:
• Leading practices and recommending improvements to ensure inspection-ready at all times
• Maintaining and coordinating inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit
• Building and implementing tools to improve inspection readiness
• Identifying trends in recent regulatory inspections and translate this to recommendations to improve readiness
• Collaborating with other regulatory compliance team to close gaps and improve inspection readiness capabilities
• Interacting with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters
• Responding to incoming inquires during inspections and audits and ensure timely and accurate responses
• Ensuring marketed products are in compliance with global regulatory and guidance requirements
• Defining and implementing quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations
• Working with customer/partner quality organizations
• Providing advice and direction to other company departments on quality and regulatory issues
This role may be for you if you:
• Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
• Have detailed knowledge of cGMPs
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
To be considered for this role you must hold a Bachelor's degree in chemical engineering/chemistry/life sciences and 8+ years pharmaceutical/biotechnology industry experience for the Sr Manager level, 10+ years experience for Associate Director level. Level to be determined based on qualifications relevant to the role.
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.