- Eisai, Inc (Raleigh, NC)
- …in regulatory inspections. Able to handle a broad scope of quality assurance work, including reviewing documentation, communicating with individuals ... Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.Audit and Compliance: Maintain audit readiness,… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Analytical Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology ... combination products. This role will report to the Sr. Director of GMP Quality Assurance ....demonstrated ability to innovate and influence peers to achieve quality objectives. * In-depth familiarity with biologics … more
- Fujifilm (Thousand Oaks, CA)
- …Assessments and maintaining a list of qualified Risk Facilitators. **Reports to** Associate Director of Compliance **Work Location** Thousand Oaks, CA **Travel** ... and drive - what we call Genki.** The Specialist QA , Compliance supports the Cellular Therapy GMP quality...with 4+ years of applicable industry experience; or + Associate Degree with 6+ years of applicable industry experience;… more
- Fujifilm (College Station, TX)
- …the hub of innovation, representing a source of pride for the area. The Senior Quality Assurance ( QA ) Analyst, under minimal direction, will be responsible ... in absence of or in conjunction with their manager. **Reports to** Director /Senior Manager/Supervisor, Quality Assurance **Work Location** College Station,… more
- Fujifilm (College Station, TX)
- …nestled in the hub of innovation, representing a source of pride for the area. The Quality Assurance ( QA ) Manager, QA Validation, will be responsible for ... policies and site SOPs to ensure regulatory compliance. **Reports to** Director , QA Compliance **Work Location** College Station, TX **Primary… more
- Fujifilm (College Station, TX)
- …to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance ( QA ) Specialist II for Data Integrity will be ... based on business priority and risks. **Reports to** Senior Director , QA Compliance **Work Location** College Station,...all levels of the FDBT site to instill a ' Quality Culture' by coaching in the application of GMP… more
- Fujifilm (College Station, TX)
- …representing a source of pride for the area. **_Summary_** **:** The Senior Director QualityOperations - Shared Services isresponsible for QA oversight of CGMP ... experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role. **_Preferred Qualifications:_** + At least 5 years of direct experience… more
- Boehringer Ingelheim (Ridgefield, CT)
- …impact on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for ... benefit programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the… more
- Organon & Co. (Plymouth Meeting, PA)
- … in Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director ) is responsible for ... understanding of related fields (eg, pharmaceutical manufacturing, analytical testing, and quality assurance ). Leadership Skills + Demonstrated ability to… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …deviations, external and internal audit findings. + Supply technical and pertinent quality assurance information to external and internal customers. Maintain ... will be required. **Summary:** Under the supervision of the Director of Quality , ensure donor centers in...as a thorough understanding of quality systems, quality control and quality assurance … more
- Takeda Pharmaceuticals (Lexington, MA)
- …owners on system changes and communications. You will report to the Associate Director of Digital and Lab Systems Quality Assurance . **How you will ... Systems (eg LabWare LIMS, MODA) to support the Massachusetts Biologics Operations (MBO) site. You will maintain master data...At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict… more
