Manager GMP Compliance and Inspections

Responsibilities

• Ensure readiness for regulatory inspections and partner/other audits by creating, maintaining, and managing inspection content, ensuring it is organized, current, and readily accessible at all times.
• Plan all inspection and audit logistics and scenarios, including communication plans, room allocations, backroom/frontroom configurations, technology checks, and personnel assignments.
• Perform a lead role in the audit/inspection backroom and respond to incoming requests during inspections and audits, ensuring timely and accurate responses.
• Evaluate outcomes of regulatory authority inspections/partner and other audits to identify near misses, lessons learned, and other best practices, and work cross functionally to ensure identified process or system improvement opportunities are sustainably implemented.
• Coordinate inspection/audit responses and actively manage commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
• Collaborate with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, confirming timely closure and implementing suitable effectiveness checks.
• Maintain and enhance communication processes to site management on the status of regulatory inspection readiness and CAPA commitments, including development of appropriate KPIs.
• Generate, develop, and report metrics/trends for program adherence to requirements and effectiveness.
• Participate in proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
• Utilize strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems.
• Support and lead teams implementing practices and improvements to make IOPS inspection ready at all times.
• Build and implement tools to improve IOPS inspection readiness; determine system improvements through effective project management.
• Develop and deliver training on inspection conduct, backroom/frontroom protocols, and regulatory expectations.
• Work with department leaders and cross functional teams to educate, building and maintaining an inspection readiness structure across the organization.
• Liaise with partners on audit/inspection and quality related matters to provide guidance and advice.
• Participate on internal committees/teams as required.
• Provide cross site support of inspection readiness and inspection activities.
• Coordinate Regeneron information to support regulatory requests for paper inspections and/or observation responses.
• Perform additional duties as required.

Qualifications

• Strong project management, interpersonal, cross cultural, communication, negotiation, and problem solving skills.
• Ability to understand and listen to team members and stakeholders while fostering a productive team environment toward a common objective.
• Driven for proactive resolution of issues with tact, diplomacy, and composure.
• Resilient and flexible in the face of challenges and adversarial situations.
• Capable of providing clear direction in ambiguous situations and environments.
• Knowledge of industry practices and regulations.

To be considered for this role you should have a BA/BS degree in Life Sciences and the following minimum years of relevant experience for each level:

• Associate Manager: 6+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.
• Manager: 7+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent combination of education and experience.
• Level will be determined based on qualifications and experience relevant to the role.

EEO Statement

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 hereby provides reasonable accommodation to the known disabilities or chronic illnesses of qualified applicants unless such accommodation would impose undue hardship on the operation of the Company's business.