- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The incumbent uses systems thinking… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency auditsEnsure site/system validation program meets FDA , ... Biochemistry, Biology, or related science fieldDemonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in… more
- Lundbeck (Greensboro, NC)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Novo Nordisk Inc. (Boulder, CO)
- …for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory supporting ... 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the...to learn new IT applications Demonstrated knowledge of US FDA , ICH Q7, & ISO regulations, guidelines, and applications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary The Study Associate Manager , under the guidance of the Associate Director, will supervise a group ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... Affairs. Other relationships may include Convention Marketing and Sales Training. The Manager may represent Medical on PRB working group, brand teams/extended brand… more
- Lundbeck (College Station, TX)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. Build, lead,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... preparation for and during internal and external regulatory audits (including FDA , EMEA).Responsible to maintain permanent inspection readiness and actively support… more
- Lundbeck (Oakland, CA)
- …transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and/or materials management preferred1 or More Years of knowledge of FDA requirements preferredAbility to travel up to 20% Primary travel to domestic ... contract manufacturing locations and to global DS sites as required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual… more
- Butterball (Clinton, NC)
- …are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.4. Partners to ensure ... implement improvements. Recommends changes to policy as needed.6. Assists the Mill Manager to prepare annual budgets to include volumes and dollars. Responsible for… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... clinical assets, programs, and studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and implement… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure… more
- Novo Nordisk Inc. (Durham, NC)
- …and scheduling experience for this area is a plus. Relationships Manager . Essential Functions Execute production plans by leading the operation, monitoring ... activities Address any safety, quality, staffing or personnel issues & escalate to manager as may be necessary Monitor performance & completion of training to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review of ... environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry. -Schedule: Monday - Friday, 6:00 AM - 2:30 PM EST (will… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and information from established internal contacts; consults with Supervisor/ Manager for decisions outside establishedprocesses.Provide guidance to other employees ... compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in… more
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