- Twist BioScience (South San Francisco, CA)
- Director /Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated ... Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization...FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system… more
- Eisai, Inc (Exton, PA)
- … Control , Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and emerging ... with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions… more
- Eisai, Inc (Raleigh, NC)
- …If this is your profile, we want to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for providing ... and/or transition plans to meet the demand forecast. The Director , Western SCM Unit will lead a cross-functional team...an uninterrupted supply of quality products to our patients, internal DCU customers, and select Partners, both domestically and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and advises various NNI stakeholders on financial, contractual, employee benefits and internal control related matters with heavy interface with senior ... this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls, and Director...Responsible for establishing a strong and sustainable environment of internal control compliant with Sarbanes Oxley Sec… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, etc.) of animal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and strategic alignment through actionable… more
- Merck & Co. (Rahway, NJ)
- …As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify opportunities… more
- Merck & Co. (Rahway, NJ)
- …audit and assurance services.Position Overview / Function and ResponsibilityThe Associate Director :Leads a small team through financial and compliance audits and ... across all our company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Merck & Co. (Durham, NC)
- …a successful Validation support of the vaccine manufacturing facilities.The Associate Director , Validation will be responsible for providing Validation leadership as ... team within the Technical Operations organization.Position Responsibilities: Reporting to the Director , Validation the incumbent will lead the team of validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of… more
- Repligen (Waltham, MA)
- …compliance teamResponsibilitiesGlobal Compliance Leadership:Develop, implement, and maintain an effective internal control framework that spans all global ... and control functions across the organization.Oversee the coordination of internal and external audits, ensuring all findings are addressed promptly and… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory submissions Support… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... the Head of Biologics Cell Culture Sciences and working in conjunction with internal and external partners, this individual will support late stage and commercial… more
- Merck & Co. (Rahway, NJ)
- …all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or ... Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.Problem Solving:-Remove roadblocks, resolve… more
- Raytheon (Tewksbury, MA)
- …customers with unmatched capabilities of detection and sensing, command and control , and air-to-air, air-to-surface, and surface-to-air munitions to accomplish air, ... on large terrestrial radars, precision munitions, and integrated command and control (C2) solutions.The Raytheon Engineering Technology team is seeking a Technology… more
- Merck & Co. (Durham, NC)
- …a critical role in supporting the Operations Management team, partnering with internal stakeholders, and building the operations team.Members of the Operations team ... plan - Receives guidance and oversight from Operations Associate Director and DirectorInterprets client and/or customer needs and assesses requirements.Applies… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Merck & Co. (Rahway, NJ)
- …team and/or department via presentations to governance committees and other internal audiences.Partnering with director -level management to develop and execute ... guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... positive impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate in… more
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