- Fujifilm (Holly Springs, NC)
- …will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will ... leadership, and team management experience * Experience in cGMP manufacturing operations and/or Quality role in an FDA /EMA regulated facility. * Experience and… more
- Astellas Pharma (Westborough, MA)
- …of qualification and validation procedures and practices in accordance with global regulatory bodies ( FDA , EMA, ICH, Japan guidance), Astellas policies and ... maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across a broad… more
- Bayer (Indianola, PA)
- …code; + Ensure development initiatives comply with Bayer Standard Operating Procedures and meet regulatory standards such as FDA 21 CFR 820.30, FDA ... the development of medical devices, ensuring the delivery of high- quality products that meet or exceed customer expectations and...that meet or exceed customer expectations and comply with FDA design controls. You will be involved in all… more
- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- Unither Pharmaceuticals (Rochester, NY)
- …and Capsules. It has more than 280 employees. Your role Reporting to the Quality Director, JOB SUMMARY: This is a team-oriented position with the individual actively ... necessary controls and mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as… more
- Atlantic Health System (Summit, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. Regulatory Compliance (CAP, CLIA, JCAHO, FDA ): + Updates and monitors ... reports workload statistics to the Site Manager. + Reports Quality Control, Proficiency Testing and Quality Improvement...Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as… more
- Integra LifeSciences (Princeton, NJ)
- …complete product solutions to the market. + Engage with R+D, Marketing, Quality , Regulatory , Planning, Medical Safety, Procurement and Manufacturing groups to ... for the function, determining skill needs, talent acquisition, adherence to quality processes, performance management, staff development, and allocation of resources… more
- Conagra Brands (Chicago, IL)
- …Brands. You will partner with internal departments and functions including Quality , Engineering, Thermal Processing, Sanitation, Scientific and Regulatory ... enterprise. + Ensure the adoption of best food safety and quality practices across the organization including pathogen environmental monitoring programs, food… more
- GN Hearing (Shakopee, MN)
- …Cross-functional coordination experience, for example, regular interaction with R&D, Regulatory Affairs, Manufacturing, Supplier Quality , Customer Service. ... cases, the Sr. Customer Solutions Specialist also provides support to Global Product Quality and direct support and guidance to local NA Product Quality … more
- Teva Pharmaceuticals (West Chester, PA)
- …Director, Senior Counsel, Global R&D Compliance role reports into our Global R&D, Quality , and Regulatory Legal organization. This position will provide legal ... legal support for internal investigations. + Work cross-functionally with Quality , Regulatory , IP, Compliance, Privacy, and other...+ Past experience working for a health authority (eg, FDA , EMA) preferred. + Admission to practice law in… more