- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.Coordinate and ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Merck & Co. (Rahway, NJ)
- … Assurance: Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:… more
- Merck & Co. (Rahway, NJ)
- …delivery systems.Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Durham, NC)
- …build and maintain strong and trusting relationships with site technical operations, quality , regulatory , stability, and other stakeholders to ensure effective ... is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and… more
- Merck & Co. (Millsboro, DE)
- …accountable for IPT performance against site and division goals, including quality , safety , delivery, cost of goods, and budget forecasts.Translate ... leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory … more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... and ensure that all platforms (eg syringes, auto injectors, bottles, blisters) meet safety , efficacy, quality , and robust supply standards. Drive proactive risk… more
- Merck & Co. (Rahway, NJ)
- …a single-use environment, and bioprocessing equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for ... key stakeholders.Training skills: Ability to train employees in technical, compliance, safety , and environmental procedures; ability to write SOPs and technical… more
- Merck & Co. (Rahway, NJ)
- …that all solutions (eg thermal containers, package designs, new components) meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams and stakeholders to ensure that all platforms meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to facilitate… more
- Merck & Co. (North Wales, PA)
- …supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate ... competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization,… more
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory ... manufacturing, enhance data monitoring capabilities, and drive excellence in safety , compliance, supply, and productivity.Global Impact:Collaborate with colleagues across… more
- Tris Pharma (Monmouth Junction, NJ)
- …to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety , quality , and regulatory standards in warehouse operationsManages, ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific… more
- Merck & Co. (Durham, NC)
- …technical support and training to mechanics and other maintenance personnel.Interface with safety , production, and quality groups to ensure facility operations ... of preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements and goals.Track maintenance and… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... Director in Biologics Cell Culture Sciences group and working...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful ... teams to ensure that all platforms (eg syringes, auto injectors, kits) meet safety , efficacy, quality , and robust supply standards. Develop and maintain strong… more
- Dartmouth Health (Bennington, VT)
- …Vermont Medical Center seeks a full-time Assistant Director of Patient Safety , Quality & Regulatory Accreditation. The position provides leadership ... patient safety . Focused on optimizing the organization’s compliance with regulatory accreditation requirements and the organizations quality and safety… more
