- Exela Pharma Sciences, LLC (Lenoir, NC)
- …capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of ... processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process… 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 ... phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operation of the… 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
- 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)
- …production planning and/or materials management preferred1 or More Years of knowledge of FDA requirements preferredAbility to travel up to 20% Primary travel to ... Control and Shipping/Receiving. Ensures that systems and software [SAP: Material Requirements Planning (MRP), Purchase Order Management, Inventory Management] are in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR rules, ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… 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 ... or more work cells Enforce all safety & environmental requirements in the performance of duties Help facilitate a...safety, quality, staffing or personnel issues & escalate to manager as may be necessary Monitor performance & completion… 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 ... two (2) years of experience in an GMP or FDA regulated industry. -Schedule: Monday - Friday, 6:00 AM...a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …the following is desired: Microsoft Windows Operating Systems and Networking systems (Ethernet) FDA and EMEA Regulatory requirements Experience at a medium to ... will be commisserate with experience. Relationships Reports to: Automation Manager Essential Functions Responsible for assisting with the design, implementation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …consistent with the safety policies, quality systems and cGMP requirements .Critically support investigations and reports, interpret results, and generate technical ... resources and information from established internal contacts; consults with Supervisor/ Manager for decisions outside establishedprocesses.Provide guidance to other employees… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Way and 10 Essentials in all activities and interactions with others Physical Requirements Local and International travel: 0-5%. The ability to stand, crouch, walk,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- * Manager , Regulatory Affairs Date: Apr 2, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 61105 **Who we are** ... people to make a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: + Prepare, review and approve regulatory submissions (ie ANDAs,… more
- Ingersoll Rand (Durham, NC)
- …+ Lead the preparation for internal and external audits, ensuring readiness for FDA inspections and ISO certifications. ** Requirements ** : + Bachelor's degree in ... information visit: www.irco.com. **Position Objective:** We are seeking an experienced Production Manager to lead and optimize our manufacturing operations in an … more
- University of Michigan (Ann Arbor, MI)
- Laboratory Accreditation and Compliance Manager Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as ... and other administrative functions) are compliant with all regulatory requirements , including but not limited to CLIA and the...to the Department of Pathology (eg, New York, California, FDA , etc.) + Suggests and helps implement training with… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …solutions. . We are seeking a highly skilled and motivated Sr Clinical Trial Manager to join our team and lead clinical studies focused on cardiac biomarkers in ... an FDA -regulated environment. Job Description: We are seeking an experienced...seeking an experienced and highly motivated Senior Clinical Trial Manager to lead and oversee clinical studies focused on… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …Hygiene by following and ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements . + Leads or participates in ... **Summary** We are actively recruiting for an experienced Sanitation Manager for our Lewiston Harvest facility. This position will... Proficiency** + Capable of incorporating applicable USDA / FDA /FSMA requirements into plant procedures as… more
