Regulatory Compliance Project Lead

4 days ago


Fremont, California, United States Catalyx Full time
About the Role

Catalyx is seeking a skilled Compliance Specialist to join our team. As a key member of our manufacturing operations, you will play a vital role in ensuring compliance with regulatory requirements.

This is an exciting opportunity for an individual contributor who is passionate about delivering high-quality results and driving continuous process improvement. If you have experience in managing change control records, leading projects, and identifying areas for improvement, we want to hear from you

About You
  • Must possess knowledge in the area of manufacturing bio-pharmaceuticals
  • Has experience in managing simple to moderate projects, and CAPA
  • Possesses knowledge of cGMP systems and regulations from different regional jurisdictions
  • Some experience leading meetings, and mastery of techniques to keep meetings effective and team on task
Requirements
  • Bachelor's Degree with a focus on Bio-pharmaceuticals
  • Experience in biotech, pharmaceutical manufacturing is a requirement
  • Preferably experience as a manufacturing operator or technician
What We Offer

We offer a competitive salary of $65,000 - $75,000 per year, depending on experience. Our benefits package includes comprehensive health insurance, retirement plan, and paid time off.



  • Fremont, California, United States Spectrum Health Full time

    About the RoleThis is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Ludington and Gerber Hospitals.About Corewell HealthWe are a health system committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace...


  • Fremont, California, United States Yoh Full time

    Regulatory Affairs Associate IYoh is seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will assist in preparing responses to global information requests and related maintenance documentation, determine regulatory strategies for manufacturing changes and regulatory...


  • Fremont, California, United States Catalyx Full time

    Job Description:Catalyx seeks a skilled Compliance Specialist to manage change control records and lead projects in support of Manufacturing Operations. This position will support the monitoring and reporting of deviations, change controls, and improvement projects. The role involves owning and maintaining change control records, CAPAs, and Periodic Review...


  • Fremont, California, United States Tesla Full time

    Job Summary: Tesla is seeking an experienced Electrical Superintendent to join our construction team. The successful candidate will be responsible for managing an internal team of electricians, ensuring compliance with plans and specifications, and tracking project schedule and budget. 2 medical plan options with $0 payroll deductionFamily-building,...


  • Fremont, California, United States San Francisco Bay University Full time

    About the Position:The Chief Financial Officer (CFO) is a key member of the San Francisco Bay University leadership team. Reporting directly to the university president, the CFO is responsible for the financial management of the institution, including financial reporting, cash and investments management, budgeting, forecasting, audit, tax, and financial...


  • Fremont, California, United States FPI Management, Inc. Full time

    Job SummaryFPI Management, Inc. is seeking a skilled Maintenance Technician to join our team. As a key member of our maintenance team, you will be responsible for ensuring the upkeep and maintenance of apartment homes, buildings, and grounds.Key ResponsibilitiesPerform routine maintenance tasks, including repairs to flooring, drywall, and...


  • Fremont, California, United States GForce Life Sciences Full time

    Key Responsibilities:Execute routine and non-routine biochemical and chemical analysis of raw materials, in-process items, and finished products, adhering to established operating procedures, ensuring consistency and accuracy in testing practices.Compile and document test data, participate in stability program testing, and contribute to formulation studies,...


  • Fremont, California, United States PSG Global Solutions Full time

    At PSG Global Solutions, we are seeking a highly skilled Senior Quality Assurance Operations Lead to join our team in the Pharmaceuticals and Medical Products industry.The successful candidate will be responsible for planning and managing the work of the BI Fremont Quality Assurance group, overseeing Quality Control, and providing technical expertise on...


  • Fremont, California, United States Simply Solar Full time

    About the RoleWe are seeking a highly skilled Solar Installation Team Lead to join our team at Simply Solar. As a key member of our team, you will be responsible for overseeing the installation of solar systems, ensuring that projects are completed on time, within budget, and to the highest quality standards.Key ResponsibilitiesOversee the daily workflow of...


  • Fremont, California, United States Tripart Full time

    Restaurant General ManagerAt Tripart, we're looking for a talented Restaurant General Manager to join our team. As a key member of our management team, you'll be responsible for leading our restaurant operations and ensuring that our customers receive an exceptional dining experience.Key Responsibilities:Lead and motivate our restaurant team to achieve...


  • Fremont, California, United States Siemens Industry Software Inc. Full time

    Job Title: Senior Manager of Manufacturing EngineeringJob Summary:Siemens Industry Software Inc. is seeking a Senior Manager of Manufacturing Engineering to lead our manufacturing engineering team. The successful candidate will be responsible for managing and leading a team carrying out quality assurance engineering and manufacturing engineering initiatives,...


  • Fremont, California, United States Neuralink Full time

    Job Summary:We are seeking a highly skilled Design Assurance Engineer to join our team at Neuralink. As a key member of our engineering organization, you will be responsible for ensuring that our software meets the highest standards of quality and regulatory compliance.Main Responsibilities:Develop and execute design control activities to ensure compliance...


  • Fremont, California, United States Bob Evans Restaurants Full time

    Restaurant Operations ManagerWe are seeking a skilled Restaurant Operations Manager to join our team at Bob Evans Restaurants. As a key member of our management team, you will play a critical role in driving sales growth, improving customer satisfaction, and maintaining operational excellence.About the Role:The Restaurant Operations Manager will be...


  • Fremont, California, United States Info Way Solutions Full time

    Database Architect & DB AdminWith over 15 years of experience in product development and data management, we are seeking a highly skilled Database Architect & DB Admin to join our team at Info Way Solutions.Key Responsibilities:Design and implement scalable data storage solutions to meet enterprise needs.Develop and maintain high-performance database...


  • Fremont, California, United States Yoh Full time

    Job DescriptionWe are seeking a highly skilled Biochemical Process Engineer to join our team at the Fremont facility. This is a contract opportunity for a 1-year period, with the possibility of extension.Job Summary:Evaluate, transfer, and implement new processes into the Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.Provide...


  • Fremont, California, United States WELLS FARGO BANK Full time

    About this RoleWells Fargo is seeking a Senior Branch Network Management Trainee to join our Consumer, Small and Business Banking division. This is an exciting opportunity to develop your leadership skills and contribute to the success of our branch network.Key ResponsibilitiesLead and manage a diverse team of direct and indirect reports, fostering a culture...


  • Fremont, California, United States Compass Group USA Full time

    Job SummaryWe are seeking a highly skilled and experienced Financial Operations Manager to join our team at Compass Group USA. This is an exciting opportunity to work in a dynamic and growing company, with a focus on delivering exceptional financial results.Key Responsibilities:Manage the day-to-day financial operations, including payroll, benefits, and...


  • Fremont, California, United States Joulé Full time

    Job Title: Senior Process EngineerApply after reading through all the details and supporting information regarding this job opportunity.Responsibilities:Evaluate, transfer, and implement new processes into the company's Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.Process transfers of internal company products and external...


  • Fremont, California, United States Department of Transportation Full time

    Job Description and DutiesUnder the general direction of the Department of Transportation, the incumbent is responsible for providing compliance documents in accordance with federal and state laws and regulations applicable to cultural resources, including the National Environmental Policy Act (NEPA) and the California Environmental Quality Act (CEQA), for...


  • Fremont, California, United States K.A. Recruiting Full time

    Our partner, a renowned reference laboratory in the United States, is searching for a skilled Laboratory Manager/Supervisor to oversee multiple laboratories. This laboratory is committed to adhering to rigorous quality standards and process controls to meet state and local regulatory requirements.The ideal candidate will be an ASCP Certified Clinical...