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Associate Director
4 months ago
Associate Director, GPS Inspections and Audits
~ This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety. Such activities include, but are not limited to, ensuring GPS inspection readiness, leading GPS facilitation for all GPS-impacted audits and inspections, and supporting the development and implementation of corrective actions and preventative actions.
Maintain inspection and audit readiness for GPS, including building and maintaining a content repository to support inspections and audits.
Identify trends in recent regulatory inspections and develop implementation plans for continued inspection readiness and process improvements.
Lead proactive evaluation and education of GPS compliance against current and emerging regulatory trends.
Liaise with GPS subject matter experts, Regulatory Affairs, Medical Affairs, and other key functions as related to GPS inspection readiness and proactively identify potential trends or significant non-compliance.
Point-of-contact for GPS related audits and inspections, working closely with GD Quality and Inspection Management to facilitate preparation, execution, and follow-up on all GPS-impacted audits and inspections.
Coordinate GPS responses to inspection and audits.
Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events as needed.
Provide support for quality and compliance of additional GPS deliverables including updating the PSMF as related to GPS Quality & Compliance deliverables.
Assist in review and contribution to Global Patient Safety Quality and Compliance-related documented procedures.
Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions.
Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
