Sr Manager, GxP Compliance Officer

Job Summary The Sr. Manager, GxP Compliance Officer (GCO) oversees compliance for all manufacturing sites and R&D centers active in US-FDA regulated activities. The role ensures adherence to cGMPs, cGLPs, and electronic record requirements, promotes continuous quality improvement, and coordinates company-wide compliance initiatives across Fresenius Kabi’s global facilities. Responsibilities Lead coordination, verification, and tracking of global compliance activities within the pharmaceutical division. Evaluate investigations and changes that may impact regulatory commitments. Identify and remediate plant quality and compliance risks through metrics, audit results, gap assessments, and other assessments. Support plant strategy and compliance plans for identified gaps. Lead and manage working groups to ensure mitigation plans are executed. Prepare manufacturing sites and R&D centers for upcoming US‑FDA inspections, including staff training, mock inspections, and need‑based training. Provide immediate guidance and support during inspections, both in the inspection room and back office. Support and guide the preparation of responses to FDA‑483 observations. Conduct independent reviews of the effectiveness of assigned FDA‑483 CAPAs. Perform inspections by local authorities related to Mutual Recognition agreements (as applicable). Identify new FDA cGMP trends and develop strategies to meet emerging expectations. Strategically optimize and harmonize cGMP and quality-related processes to continuously improve pharmaceutical quality and compliance. Prepare global quality management documents, such as SOPs, guiding documents, and working instructions. Execute and manage global projects and collaborate with corporate quality functions on strategic goals. Communicate findings and risks to plant management and senior quality management. Qualifications Minimum bachelor’s degree required; advanced degree in chemistry, molecular biology, microbiology, or engineering highly desirable. Accomplished US‑FDA compliance expert with 8+ years of practical experience in the pharmaceutical industry and/or US‑FDA settings. Thorough knowledge of drug transfer processes and manufacturing processes for aseptically filled, terminally sterilized, and lyophilized pharmaceuticals. Expertise in cGMPs, ICH guidelines, regulatory compliance, validation, qualification, risk management, root cause analysis, and investigation management. Experience executing and/or managing GxP audits or inspections preferred. Ability to interact effectively with plant personnel, leadership, regulators, global partners, industry executives, and trade organizations. Established relationships with US‑FDA beneficial. Strong analytical and problem‑solving skills. Demonstrated leadership in motivating teams to develop innovative and sustainable solutions. Capacity to manage multiple complex scenarios where precedent is not established. Comfortable navigating ambiguity and uncertainty in decision making. Must be willing and able to travel domestically and internationally frequently. Project management experience, familiarity with Quality Management Systems, and strong communication skills required. Bilingual English/Spanish preferred. Benefits 401(k) plan with company contributions. Paid vacation, holidays, and personal days. Employee assistance program. Health benefits including medical, prescription drug, dental, and vision coverage. Equal Opportunity 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. #J-18808-Ljbffr 301095 Fresenius Kabi, LLC