- Cognizant (Boston, MA)
- …**Required Qualifications:** * **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 CFR ... Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. Proven track record in preparing for internal and external… more
- Cognizant (Boston, MA)
- …yrs. of experience :_** **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 CFR Part 11, ... Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. - Proven track record in preparing for internal and… more
- ZOLL Medical Corporation (Boston, MA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... content that promotes ZOLL's technologies through digital platforms and social media. Compliance & Budget Management : + Ensure all professional relations activities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …indicators to Leadership. + Maintains current and up to date knowledge on FDA Regulations and Guidance documents and enforcement action letters as applicable to ... of policies/processes that reflect best practices and are in compliance with Takeda policies/processes. + Works closely with Scientific...MD or Ph.D., with a thorough grasp of the pharmaceutical industry. + 3-5 years of managing people. +… more
- Fujifilm (Boston, MA)
- …diagnosed per year, number of hepatologists). + Adheres to company and compliance guidelines, policies, and procedures. + Effective communication within FUJIFILM IVD ... organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Charles River Laboratories (Cambridge, MA)
- …veterinarians, veterinary technicians, trainers, and the IACUC office to ensure compliance with biosecurity policies and procedures, IACUC required training, IACUC ... non- compliance and/or animal welfare concerns. + Responsible for personnel...our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and… more
- Stantec (Boston, MA)
- …to bio- pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in GMP ... and automated systems which require qualification and validation for compliance . The commissioning and validation of equipment, facilities, utility systems… more
- Charles River Laboratories (Cambridge, MA)
- …rack sanitation, PPE/supply stations and waste management). + Ensures compliance and documentation with all institutional and regulatory protocols, policies, ... wash team operations. + Continuously support vivarium management in maintaining compliance with all internal (IACUC) and external (USDA-APHIS, PHS-OLAW,) regulatory… more
- ThermoFisher Scientific (Plainville, MA)
- …& Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance , operates within budgets, and supervises bioanalytical lab staff directly and QC ... Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance , accuracy, and timeliness of testing processes. Lead the introduction of… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide ... timelines + Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments + Lead the planning and… more