Compliance Manager
Meet Life Sciences
The Compliance Manager oversees compliance, quality standards, and inspection readiness activities within Regulatory Affairs. This role monitors regulatory compliance metrics, supports process improvements, ensures training and SOP compliance, and collaborates cross‑functionally to maintain adherence to global regulatory requirements and operational excellence. Responsibilities Monitor regulatory compliance metrics, RFIs, aggregate reports, and inspection readiness activities. Ensure accuracy and maintenance of RSI trackers, TMF documentation, Veeva RIM records, and RA training compliance. Support SOP management, quality events, CAPAs, deviation assessments, and impact assessments for evolving regulations. Partner with Clinical Operations, Quality Assurance, CROs, and cross‑functional stakeholders to maintain compliance standards. Develop dashboards, reports, and presentations summarizing compliance trends and performance. Author and maintain Regulatory Affairs procedures, standards, and training matrices. Qualifications Bachelor’s degree with 5–7 years or Master’s degree with 3–5 years of relevant experience. Minimum 5 years of Regulatory Affairs experience within the pharmaceutical industry. Knowledge of regulatory compliance, audits, inspections, SOPs, CAPAs, and quality systems. Experience managing multiple priorities in a fast‑paced, regulated environment. #J-18808-Ljbffr Meet Life Sciences
Vacancy posted 4 days ago
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