- Aequor (Thousand Oaks, CA)
- …Coordinate Global Incoming Quality Process Operations to support Global Process Owner lead . Interface with IQA Network, various sites and business ... partners to ensure maintain process in compliance and alignment. Complete and approve multisite...and approve multisite procedures, deviation, change control and other quality records to support RM Network. Candidate must have… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process improvements.Participate/facilitate in escalations ... position is an exempt level position. The position's responsibilities include providing quality oversight over process improvement projects within a cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Strategy role is an exempt level position with responsibilities for providing quality oversight over process improvement projects within a cell therapy ... in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous...input for site CI and remediation efforts.Schedule and manage Quality tasks associated with process improvements.Act as… more
- Merck & Co. (Rahway, NJ)
- …Operational Excellence. The role also involves strategic partnering with Development Quality , Process Research & Development, Pharmaceutical Operations, and ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include:… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of… more
- Merck & Co. (Rahway, NJ)
- …the local policies of work commuting.Essential responsibilitiesManages a team of Quality Assurance professions as direct reports and complies with company ... and review of annual product reviews. This also includes building effective quality systems at the CTLs and continuous improvement activities.Assures compliance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …(OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, ... Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Risk Assessment plans with milestones and deliverables in collaboration with stakeholders ( Quality , production, engineering, QC and process improvement and R&D ... recommendations and implement modifications to risk assessment plans.Key Responsibilities Follow QRM ( Quality Risk Management) process per ICH Q9, identify the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful ... products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the… more
- Eisai, Inc (Los Angeles, CA)
- …your profile, we want to hear from you. Job Summary: The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and ... KOLs, Pathway and P&T committee members). Each ABL will lead account responsibility for a defined number of potential...limited to CEO, CFO, CMO, Case Management, Dir. of Quality , Industry Relations, Technology Dir, etc.).Evaluate unique needs of… more
