Reference #: R009990Job Summary

　　The Senior Director US FDA compliance will manage multiple complex situations where precedents have not been established. Assure that all plants and I&D centers having activities with US-FDA are in compliance with the specific US-regulations including but not limited to, cGMPs, cGLPs, and cGCPs. This includes foreign facilities within Fresenius Kabi for importation of API or finished products to the US market. This position will be responsible for both Medical Devices and Pharma products with Fresenius Kabi MedTech.

　　*Priority will be given to candidates in proximity to our Lake Zurich, IL site, followed by candidates who would be based remotely.

　　Responsibilities

　　Manage US GMP and Medical Device (QSR) regulations, and Pharma regulations, guidance, and FDA expectations.Support any FDA remediation activities such as leading follow up in case of FDA observations (483), untitled letters, and other FDA questions.Stay updated on Field Corrective Actions, FAR/MDR-reporting and 483s of competitors.Identify new trends in FDA expectations and determine strategy and implementation plan to fulfill these new expectations.Prepare plants for and support during and if needed after FDA GMP or MDSAP-inspections.Perform mock audits for FDA readiness of the location and develop strategy to mitigate gaps.Participate in Expert Circles (ECs) and Corporate Emergency Committees (CECs) to provide input of US regulations and FDA expectations regarding Field Corrective Action (FCA) decisions.Maintain contacts:External: FDA, authorities, and notified bodies.Internal: cross functional directors of business partners of Production Units and Business Units, senior management, project teams, plant QAs, Competence Centers.

　　Job Requirements:Bachelor's Degree required, Master's preferred.10+ years of QA experience: including QSR 820.5+ years' (senior) leadership experience.8+ years' experience at FDA and / or at a medical multinational and pharmaceutical being responsible for US compliance.Established contacts to FDAExperience with the preparation for and follow up of GMP / MDSAP FDA inspectionsExperience with auditing QSIT, ISO 13485, MDSAP, GMP Experience with Pharma product, active devices and / or medical disposables Internationally orientedExpert on Quality System Regulations QSR 820 / GMP (US-FDA). Expert on FDA guidance and understanding of FDA expectations.Fluent English speaking & writing skillsWillingness to travel frequently

　　Targeted base salary range: $185,000-$250,000 annually

　　Additional Information

　　We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

　　Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

　　Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.