- Insmed Incorporated (NJ)
- …and timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed ... external contractors. Lead the transition of projects from Research into Technical Operations and through to readiness for registration and filing.Ensure all… more
- Merck & Co. (Rahway, NJ)
- …clinical development teams and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager ( Program CSPM) serves ... not limited to: - Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory,… more
- Merck & Co. (Rahway, NJ)
- …decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager , will be responsible ... the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role ... OverviewThe MES Project Manager will be part of Manufacturing Science and Technology...and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management… more
- Cipla (Fall River, MA)
- …(QA) to incorporate technical best practices including QbD principles in all technical studies. Participate and/or lead technical due diligences on ... of Cipla's respiratory business in the United States. Job Title Project Manager Organization Name InvaGen Pharmaceuticals Location 7 Oser Avenue, Happauge NY 11788… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance (QMS) Production Lead FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... vary based on business needs) Reports To : QA Manager Purpose: The purpose of the Quality Assurance Production... Purpose: The purpose of the Quality Assurance Production Lead (QMS) is to monitor and ensure product quality… more
- Repligen (Waltham, MA)
- …Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager , SOX & ITGC Compliance to lead the design, implementation, and ongoing ... reporting and key digital systems. This role drives the ITGC audit program , advises on risk mitigation strategies, and partners closely with Internal Audit,… more
- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team members. ... Train, coach, and mentor GxP system owners. Provide CSV program trainings, lunch and learns and guidance to new...on site Change Control CAB meetings as the CSV lead . Who You Are: Position Requirements (Required and/or Preferred… more
- Insmed Incorporated (NJ)
- …eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems.Project lead experience preferred.Strong experience in Clinical Study Systems is ... of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and approving validation plans,… more
- Insmed Incorporated (NJ)
- …Supply Chain & Logistics - Supplier Relationship Management team supporting the Technical Operations organization. The role will partner closely with Commercial and ... a strong collaborator, self-motivated, and able to problem-solve to influence and lead work groups. This position reports to the Director, Supplier Relationship… more
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