- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. ... Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for...each internal audit.Coordinate front room/ back room activities for health authority audits and independent audits; manage audit responses… more
- Merck & Co. (Rahway, NJ)
- … lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead ... project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant...position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well… more
- Merck & Co. (Rahway, NJ)
- …of a production staff managed by a supervisor, production and operations engineers, a compliance and improvement lead .- This role will closely partner with the ... facilitiesPreferred:Pharmaceutical industry or regulated industry (eg food) experienceAudit experience: safety , environmental, compliance /qualityPowders handling processesDemonstrated safety… more
- Merck & Co. (Durham, NC)
- …safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... Job DescriptionThe Lead Maintenance Technician is a leader with strong...stooping are required.-Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety … more
- Novo Nordisk Inc. (Boulder, CO)
- …LOTO plan Lead on site emergency coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, ... to ensure that the Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to the Associate Director,… more
- AmplifyBio (West Jefferson, OH)
- …and in an operationally ready state. Ensures the lab always maintains proper health and safety procedures. Drafting and assembly of Contributing Scientist ... direct activities to ensure that projects are conducted in compliance with federal regulations, client requirements, preclinical study protocol,...We have a bias for action, excellence, and, especially, the health and safety of our employees.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and ... Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance… more
- AmplifyBio (New Albany, OH)
- …runs, and plant operations to meet program timelines and deliverables. Ensure compliance with GMP regulations, quality standards, and safety protocols in ... are seeking an experienced and dynamic Program Management Group Lead to join our Technical Operations team. The successful...We have a bias for action, excellence, and, especially, the health and safety of our employees.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outcomes. This role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional areas. This includes: ... updating, managing lineage, and adding context metadata in a structured fashion Lead and work with functional business data stewards on data quality initiatives… more
- Merck & Co. (Millsboro, DE)
- …the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with ... the Senior Leadership Team for the Millsboro, DE biologics manufacturing site. Lead numerous projects including process improvement and safety … more
- Merck & Co. (Rahway, NJ)
- …the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the ... all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for… more
- Merck & Co. (Rahway, NJ)
- …the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the ... with a growth mindset.Position Description: The Senior Director, Global Regulatory Lead , is responsible for development and implementation of worldwide regulatory… more
- Merck & Co. (Lower Gwynedd, PA)
- …write technical reports, and to participate on cross-functional teams. Adherence to basic safety procedures in a BSL2 laboratory and compliance to regulations. ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well… more
- Aequor (Athens, GA)
- …Federal and international codes, and regulations. Communicates any issues with Environmental Health and safety department and Management to ensure safety ... and qualification to completion. Applies engineering knowledge to projects to lead project teams, increase efficiency, reduce waste, and resolve operational issues.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews ... CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global… more
- Merck & Co. (Durham, NC)
- …Maintains, cleans and prepares equipment used in production.Identifies and addresses compliance , environmental, safety , and process deviations as appropriate ... products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement....the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:Developing an ... active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a ... of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to… more
