- 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 ... Controls and Device Supplier Management objectives and build QMS...aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to… more
- Repligen (Waltham, MA)
- …leader. This is a high-impact, strategic role driving global compliance, strengthening internal controls , and leading the SOX program. Shape and execute ... compliance teamResponsibilitiesGlobal Compliance Leadership:Develop, implement, and maintain an effective internal control framework that spans all global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Responsible for oversight of financial reporting, general accounting, related internal controls , and establishment of financial policies for Novo ... this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls , and...various NNI stakeholders on financial, contractual, employee benefits and internal control related matters with heavy interface… more
- Repligen (Waltham, MA)
- …and implement any changes in SEC regulations that impact reporting requirements. Internal Controls & ComplianceMaintain and strengthen internal ... requires expertise in SEC reporting, US GAAP, and financial controls . The Director will work closely with...requests and findings.Ensure the proper design and effectiveness of internal controls for SEC reporting and accounting… more
- Merck & Co. (Rahway, NJ)
- …assessments 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 ... knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex business scenarios in accordance with… more
- 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
- Repligen (PA)
- …subject matter expert on global payroll compliance.Design, implement, and maintain effective internal controls over global payroll in accordance with SOX(Section ... OverviewThe Director , Global Payroll will lead the development and...tosupport a growing global workforce. This role ensures proper controls and payroll compliance across jurisdictions,promotes operational efficiency, and… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... salaries & travel).Country level operational study budgets.Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position is accountable for delivering critical monitoring insights to internal stakeholders, enhancing program awareness, and fostering a culture of ethics ... global ethics and compliance program. Relationships Reports to the Executive Director , Risk Insights & Management. Manages a team of compliance professionals… 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
- 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
- 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
- Formation Bio (New York, NY)
- …a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio. This ... large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key… 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
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