The Sr. Manager, FDA compliance assures that all plants and I&D centers having activities regulated by the US-FDA are in compliance with the specific GxP US-regulations, including, but not limited to, cGMPs, cGLPs, & cGCPs. This includes foreign facilities within Fresenius Kabi for importation of API or finished products to the US market. The individual will organize and promote company-wide US-FDA quality and compliance improvement efforts.
- While this position may be worked remotely with management concurrence, qualified candidates must live near a major international airport.
Responsible for leading, coordination, verification and tracking of global remediation activities within the pharmaceutical division
Compliance evaluations of investigations and changes that could have an impact on regulatory commitment
Responsible for preparation of manufacturing sites and I&D centers for US-FDA inspections together with GO, including but not limited to: d evelop and update standard plant preparation lists for announced FDA inspection and follow-up of activities.
Performance of mock inspections to determine the plants compliance with FDA requirements and readiness for FDA inspection
Training of plant staff for general compliance aspects as well as specific training for subject matter experts.
Participation in US-FDA inspections and subsequent response preparation.
Responsible for identification of new FDA GxP trends and development of strategies to fulfill new expectations.
Accomplished US-FDA compliance expert, in either an authoritative or industry role.
Direct working knowledge of US-FDA compliance programs, policy guides, and compliance positions.
5+ years including practical hands-on experience in regulated industry and US-FDA.
Minimum of bachelor’s degree required. Advanced degree in chemistry, microbiology or engineering field is highly desirable.
Ability to effectively interact with and influence suppliers/vendors, regulators, global partners or affiliates, industry executives, trade organizations. Ability to work with colleagues from other cultural areas (e.g. Asia).
Strong analytical problem-solving experience is essential. Demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative compliance solutions that are robust and sustainable.
The Sr. Manager, FDA Compliance (Global Remediation Officer) will manage multiple complex situations, where precedent may not have been established. Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual. Technological understanding of sterilization processes (terminal and aseptic systems), critical support systems, validation processes, risk management, general manufacturing processes, and non-clinical and clinical research is required to be successful in this position.
Ability to travel frequently (both domestically and internationally) is required.
Project Management and strong communication skills are required for this position.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness 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, disabilities, or protected veteran status.