Role DescriptionYou will need to interface with all site functions and the global Quality organization and you will be responsible for oversight and activities related to the management of regulatory inspections, the site auditing program, significant investigations and recall execution, CAPA management, regulatory compliance, complaints management, site quality agreements and data integrity compliance.
ResponsibilitiesLead the site wide Permanent Inspection Readiness (PIR) program, influencing all IPT's (Integrated Process Team) and CoE's (Centre of Excellence) at the site. Report to Site Leadership Team on necessary GMP improvement programs for the site to remain permanent inspection ready. Make independent decisions on the implementation of the quality management system (QMS) at the site. Managing the quality function including interacting/developing relationships with regulatory agencies in the Netherlands as well as EMA and the FDA.
RequirementsMaster's Degree in Pharmacy, Life Sciences, Engineering A minimum of 8 eight years' experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site in quality and/or manufacturing roles. Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirement Demonstrated leadership and change management skills with focus on continuous improvement Registration as Qualified Person is preferred
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.