- Insmed Incorporated (San Diego, CA)
- … quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team , and collaborates on other related ... Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight Vendor Assessment Team and is an individual contributor role. ... networking through membership in industry association(s). Essential Functions Member of NAO Quality PV Oversight Vendor Assessment team with 'Right First Time'… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/ QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 ... am EST - 4:30 pm EST.The Document Control/ QA Associate I will report directly to the ...responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Systems Lead ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. The NPI Lead ...writing, and through presentations to peers and senior leadership team . Additional Responsibilities include: Engaging with Quality … more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Repligen (Hopkinton, IA)
- …and make real-time adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively ... OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager...a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and… more
- Merck & Co. (Rahway, NJ)
- …and performance of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all ... focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance ( QA )/ Quality Control (QC)/Regulatory ... and technology make us unique, but it is our team members that set us apart; they are the...methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management,… more
- Merck & Co. (Rahway, NJ)
- …IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance ( QA ), Resource Planning, Service Delivery, ... Job DescriptionBusiness Technology PartnerOur IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational… more
- Aequor (Houston, TX)
- …knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... Teamwork Dependable and able to work well within a team . Routine interaction with Quality Assurance...processes for investigations Willing to pursue opportunities that can lead to substantial benefit, even if there are risks… more
- Repligen (Waltham, MA)
- …in the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...Senior Management team .Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules;… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... used to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a "Safety First, Quality ...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery… more
- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive rapport and working relationships within and across departments… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building,… more
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