- Merck & Co. (Rahway, NJ)
- …well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Merck & Co. (Durham, NC)
- …during tours to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance - Foster strong safety culture on the ... reporting safety issues and completing corrective/preventative actions-Drive culture of compliance through actions, consistent quality -driven decision making,… more
- Repligen (Clifton Park, NY)
- …Leadership (Primary Focus):Manage day-to-day production activities to meet EHS, Quality , Productivity, and RPS Lean objectives.Ensure compliance with ... OverviewThe Production Manager will oversee daily manufacturing operations within a...a biopharmaceutical silicone and plastics injection molding facility, ensuring compliance with cGMP, EHS, and regulatory requirements. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Merck & Co. (Boston, MA)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... regulatory audits and inspections by collaborating with stakeholders and Quality units to provide documentation and respond to inquiries.Actively drive… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an ... is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality .Responsibilities Supplier Performance Monitoring and ReportingCollect,… more
- Merck & Co. (Irving, TX)
- …direct management direction, coordinates production associates to meet production schedules in compliance with the Quality System, EHS and company policies while ... of equipment and material resources to optimize performance.Assists the manufacturing manager to ensure production schedules are met.Verifies compliance of… more
- Merck & Co. (North Wales, PA)
- …FDA regarding select US topics, primarily including: drug shortages, user fee compliance , import/exports, financial disclosure and freedom of information. This is an ... the tracking, coordinating and reporting of specified financial information to ensure compliance with the US Food and Drug Administration requirements for "Financial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and… more
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