- Merck & Co. (Durham, NC)
- …activities requiring support include the process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of ... their enthusiasm and skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities.… more
- Twist BioScience (South San Francisco, CA)
- …report directly to the Chief Accounting Officer. Key duties include leading a team of SOX compliance professionals, assessing control risks, driving and tracking ... and remediation of controls for Sarbanes-Oxley complianceLead and manage a team of SOX compliance professionals, including analysts, third-party service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. ... Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials… more
- Aequor (Thousand Oaks, CA)
- …and standards are understood and followed. Contribution: Consistent with 's Healthcare Compliance Policy and Standard Operating Procedures: o Review proposed ... experience as a paralegal, law clerk, and legal assistant Technical platforms the team uses: Salesforce Higher level in comparison to role 1. Working with advisory… more
- Merck & Co. (Durham, NC)
- …Organization including proactively providing developmental support, coaching and assistance to team members.Support compliance to Durham Site policies and ... media, biological drug substance and drug product.Strong Background in cGMP document review and approval.Strong background in cGMP compliance standards (QMS,… more
- Merck & Co. (Rahway, NJ)
- …Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) ... our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including… more
- Merck & Co. (Durham, NC)
- …to work independently and as a member of a team .Manages individual contributors (professional employees), as applicable.Contributes to the performance ... for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.Responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …hierarchies, assignment of users to roles based on authorized requests from study team members, periodic review of user access and audit trail reconciliation, ... Repository Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technology and platform support). Essential Functions Partners with PSS Program Management team to ensure vendor compliance with all quality/safety requirements; ... educates on process requirements Partners with compliance and Program Management team on build...via benchmarking, customer feedback, auditing and active call monitoring Review contacts handled by external vendor agents to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partner Quality Leads based on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in a perpetual state of ... compliance as follows:Support the Global Quality Lead(s) (GQLs) and...continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief ... the Peer-to-Peer HCP engagement ecosystem by supporting budget management, compliance , system development, operational enhancements, strategic improvements, and performance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist role is an ... of QC Lab functions to the Raritan cGMP facility to test products. Review and approval of standard operating procedures. Review and approve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment to complete tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for continuous ... consult with manager for decisions outside of established procedures.Provide direction to the team to meet department and business goals. Review , revise, or draft… more
- Merck & Co. (Durham, NC)
- …project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial ... assignments. Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal affiliates, CROs, third party vendors, and contractor to ensure compliance with study protocol. Resolves or escalates major/cross-program issues, supported ... Tool (RACT) Ensure country and site selection meet study requirements. May review critical study documents, such as consent forms, study manuals, subject recruitment… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics including ... Director will influence the strategy, lead activities, and develop a team whose roles include design and development of formulation, manufacturing process,… more
- Aequor (Libertyville, IL)
- Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.Must have 5&plus years of hands-on experience in a ... PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems supports the successful operation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The PositionThe Manager of Master Data will work within the Master Data Team and will have responsibility for Master Data implementation, quality initiatives, and ... system as well as other MDM systems within the team (Product, Patient). This role will function as liaison...but not limited to, the Information Technology, Analytics Governance, Compliance , Field Systems and Field Force teams, as well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and ... Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring...into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. Additional… more
