Compliance Specialist

Job Description: As a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long‑term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease. As the Specialist, Compliance you will lead and author GMP investigations related to deviations, nonconformances, audit findings, and other quality events in a pharmaceutical manufacturing environment. You will partner cross‑functionally with Manufacturing, Quality Control, Engineering, Validation, Information Systems, Supply Chain, and the Quality team to ensure thorough root cause analysis, effective CAPAs, and sustained regulatory compliance. You will be responsible for the timely and accurate completion of compliance documentation, supports an inspection‑ready state, and contributes to a strong quality culture through risk‑based, right‑first‑time investigation execution. With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country. Responsibilities: Investigation Leadership & Documentation Lead and author GMP deviations, nonconformances, and quality investigations. Drive root cause analysis using structured tools (e.g., 5 Whys, Fishbone, Fault Tree, human performance concepts). Ensure investigations are thorough, scientifically sound, and compliant with regulatory expectations. Facilitate cross‑functional investigation meetings and follow up on action items. Ensure investigations are completed right‑first‑time and within required timelines. CAPA Management Develop, document, implement (as assigned), and tracks effectiveness of Corrective and Preventive Actions (CAPAs). Escalate risks when CAPAs are inadequate, overdue, or ineffective. Ensure assigned action items are completed within the required timelines. Change Management Initiate Change Controls and complete assigned action tasks. Ensure assigned tasks are completed within the required timelines. Regulatory & Inspection Readiness Support inspections and internal audits. Participate in inspection back‑room support and follow‑up activities as needed. Risk Assessment & Decision Support Perform and document risk assessments (e.g., product impact, patient safety, data integrity). Identify investigation trends and recurring issues; elevate systemic risks. Quality Systems & Continuous Improvement Support continuous improvement of investigation and deviation processes. Identify opportunities to improve compliance, documentation quality, and investigation cycle time. Contribute to metrics, dashboards, and trending reports related to deviations and CAPAs. Collaboration & Training Serve as a compliance partner to Manufacturing and support functions. Support training initiatives related to deviations, investigations, and GMP expectations. Requirements: Bachelor's degree in a scientific or technical discipline or equivalent experience. In lieu of a degree, 6+ years of experience in a GMP‑regulated pharmaceutical or biotechnology manufacturing environment, including leadership of deviations, investigations, and CAPAs. 3+ years of experience in pharmaceutical manufacturing, quality, or another regulated environment, with hands‑on involvement in GMP deviations or investigations. Working knowledge of cGMP regulations, FDA guidance related to investigations and CAPA, and data integrity principles (ALCOA+). Experience writing, reviewing, and executing SOPs; proficiency with electronic quality management systems (eQMS) preferred. Strong technical writing, documentation, and organizational skills; ability to apply risk‑based critical thinking. Proven ability to facilitate cross‑functional discussions, drive accountability, and maintain independence, integrity, and professionalism. Experience with electronic compliance systems (oneERP, QA‑Track, Veeva) Proficient in Microsoft Office; familiarity with Lean Six Sigma concepts preferred. Onsite presence required; may require extended hours, off‑shift, or weekend support during investigations, audits, or inspections. Comfortable working in a fast‑paced, high‑compliance manufacturing environment. Physical Requirements Ability to work in a manufacturing and office environment, including laboratories and production areas. Ability to sit, stand, and walk for extended periods throughout the workday. Ab #J-18808-Ljbffr