Compliance Manager
3 weeks ago
We are seeking a highly skilled Compliance Manager to join our Cell Therapy R&D facility in Fremont, CA. As a key member of our team, you will be responsible for ensuring that our manufacturing processes are executed in compliance with regulations and standards.
Key Responsibilities- Provide guidance and support to the manufacturing team to ensure ongoing compliance with regulatory and internal requirements.
- Develop and deliver training programs to educate manufacturing personnel on compliance requirements.
- Conduct risk assessments to identify compliance gaps and develop mitigation strategies.
- Drive systematic problem solving (SPS) for investigations and use metrics and trends for process improvements.
- Generate change controls, perform risk, and impact assessments.
- Coordinate and document manufacturing quality events, including deviations and change controls.
- Lead investigations for manufacturing quality events and bring them to a resolution, serving as primary author of deviation reports.
- Utilize problem-solving methodologies, such as go, look, see, to establish root cause of deviations and initiate corrective actions.
- Lead meetings, aligning internal review teams and area subject matter experts on an agreed-upon investigational path forward.
- Work closely with manufacturing team to review and evaluate quality event information and trends, providing updates to leadership on status of quality events.
- Author, revise, and review controlled documents, such as batch records, logbooks, SOPs, and other cGMP documentation, to ensure compliance with written procedures.
- Lead activities for audits and inspection readiness, representing manufacturing in internal and external audits, and addressing audit findings.
- Collaborate with stakeholders to address compliance gaps identified in audits and inspections.
- Provide periodic review of department documentation and records to assess for compliance with internal and regulatory requirements, established quality standards, policies, and procedures.
- Bachelor's degree preferred (degree in the life sciences field preferred) with 7 years relevant experience.
- Minimum of Associate degree required; Associates degree requires 9+ years of experience within cell culture in a controlled environment.
- Advanced degree may be substituted for experience as appropriate.
- Minimum of three years of proven leadership experience in driving compliance and continuous improvement within Biotechnology or Pharmaceutical organizations.
- Ability to communicate to all levels of the organization, cross-functional teams, and various knowledge levels.
- Experience writing investigation, deviations, change control documentation, technical reports, batch records, standard operating procedures, and other cGMP documentation is required.
- Proven capacity to work autonomously while remaining open to input, employing diplomacy and persuasion to address challenges and achieve mutually beneficial resolutions.
- Demonstrated ability to identify, challenge, and implement potential improvements to work procedures.
- Highly motivated and comfortable working in a results-oriented dynamic research and development environment.
- Ability to lead teams consisting of members with different degrees of knowledge or ability.
- Excellent leadership, communication (oral and written), presentation, and interpersonal skills.
- Knowledge of manufacturing processes, including experience in cell culture, and aseptic handling is preferred.
Novo Nordisk Pharma is a global health care company committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. We are conducting research on stem cell therapy, which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are interested in applying to Novo Nordisk Pharma and need special assistance or an accommodation to apply, please contact us at [insert contact information].
-
Compliance Manager
2 weeks ago
Fremont, California, United States Novo Nordisk Pharma Full timeAbout the RoleWe are seeking a highly skilled Compliance Manager to join our Cell Therapy team at Novo Nordisk Pharma. As a Compliance Manager, you will play a critical role in ensuring that our manufacturing processes are executed in compliance with regulations and standards.Key ResponsibilitiesProvide guidance and support to the manufacturing team to...
-
Compliance Quality Assurance Manager
2 days ago
Fremont, California, United States Actalent Full timeJob Title: Quality Assurance ManagerActalent is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our clients' business processes and systems.Key Responsibilities:Analyze user enhancement requests to deliver solutions focused on establishing...
-
Compliance Manager
4 weeks ago
Fremont, California, United States Novo Nordisk Pharma Full timeAbout the RoleWe are seeking a highly skilled Compliance Manager to join our team at Novo Nordisk Pharma. As a Compliance Manager, you will play a critical role in ensuring that our manufacturing processes are executed in compliance with regulations and standards.Key ResponsibilitiesProvide guidance and support to the manufacturing team to ensure ongoing...
-
Compliance Manager
3 weeks ago
Fremont, California, United States Novo Nordisk Pharma Full timeAbout the RoleWe are seeking a highly skilled Compliance Manager to join our Cell Therapy Manufacturing team at Novo Nordisk Pharma. As a key member of our team, you will be responsible for ensuring that our manufacturing processes are executed in compliance with regulations and standards.Key ResponsibilitiesProvide guidance and support to the manufacturing...
-
Regulatory Compliance Lead
1 month ago
Fremont, California, United States Novo Nordisk Pharma Full timeAbout Novo NordiskNovo Nordisk is a leading global healthcare company dedicated to the discovery and development of innovative therapies aimed at improving the lives of individuals living with diabetes. Project OverviewIn our pursuit of advancing treatment options, we are engaged in pioneering research on stem cell therapy, which holds promise for enhancing...
-
Regulatory Compliance Lead
2 days ago
Fremont, California, United States Novo Nordisk Pharma Full timeAbout Novo NordiskNovo Nordisk is a leading global healthcare company dedicated to discovering and developing innovative therapies that improve the lives of individuals with chronic conditions, particularly diabetes.Position OverviewThe Compliance Manager plays a crucial role in ensuring that all manufacturing operations adhere to applicable regulations and...
-
Clinical Compliance Specialist
2 weeks ago
Fremont, California, United States Spectrum Health Full timeExciting Opportunity for a Clinical Compliance Specialist at Spectrum HealthSpectrum Health is dedicated to improving the health and wellness of individuals. We believe in a comprehensive approach to healthcare and coverage, with a focus on prevention. Our team is committed to innovation and making a positive impact on the community.Job DescriptionAssist in...
-
Senior Tax Manager
3 weeks ago
Fremont, California, United States Gotion Full timeAbout the RoleGotion, Inc. is a leading innovator in next-generation electric vehicle and energy storage technologies, with a strong presence in the global market. We are seeking a highly skilled and experienced Tax Manager to join our team and lead our corporate tax function.Key ResponsibilitiesGlobal Tax Planning: Develop and implement tax planning...
-
Clinical Regulatory Compliance Specialist
2 days ago
Fremont, California, United States Spectrum Health Full timeAbout Spectrum HealthSpectrum Health is a leading health system dedicated to delivering exceptional patient care and advancing the health of our communities. Our mission is to improve the health and well-being of the people we serve, and we are committed to providing a safe and inclusive environment for our patients, visitors, and team members.Job SummaryWe...
-
Senior Environmental Compliance Specialist
3 weeks ago
Fremont, California, United States Department of Transportation Full timeJob Description and DutiesUnder the general direction of the Office of Maintenance Environmental, Branch Chief, the incumbent is responsible for providing compliance documents in accordance with Section 106 of the National Historic Preservation Act, Public Resource Code 5024, and other federal and state laws and regulations applicable to cultural resources,...
-
RF Compliance Testing Engineer
1 month ago
Fremont, California, United States TUV Rheinland of North America Full timeJob OverviewAt TUV Rheinland, we pride ourselves on being a premier provider of testing, inspection, and certification services globally, employing over 20,000 professionals. Our workforce is our greatest asset, and we are committed to fostering their growth through competitive compensation, a variety of health insurance options, and a 401(k) plan with...
-
RF Compliance Testing Engineer
1 month ago
Fremont, California, United States TUV Rheinland of North America Full timeJob OverviewAt TUV Rheinland, we pride ourselves on being a premier provider of testing, inspection, and certification services globally, employing over 20,000 professionals. Our workforce is our greatest asset, and we are committed to their growth by offering competitive compensation, diverse health insurance options, and a 401(k) plan with generous company...
-
Financial Management Service Manager
2 days ago
Fremont, California, United States HR Alliance Full timeFinancial Management Service Coordinator (Bilingual - Spanish)We are seeking a highly skilled and detail-oriented Financial Management Service Coordinator to join our team at HR Alliance. As a key member of our team, you will play a critical role in supporting individuals and families participating in the Self Determination Program.Key...
-
Pharmacy Manager
2 weeks ago
Fremont, California, United States Walgreens Full timeJob Description:Job Summary:As a Pharmacy Manager at Walgreens, you will be responsible for providing exceptional patient care and leading a team of pharmacists and technicians to deliver high-quality pharmacy services. You will be the face of our pharmacy, ensuring that patients receive accurate and compassionate care, while also driving business growth and...
-
Facilities Operations Manager
4 weeks ago
Fremont, California, United States Compass Group Careers Full timeJob SummaryWe are seeking a highly skilled and experienced Facilities Operations Manager to oversee the maintenance and upkeep of our facilities, equipment shop, and fleet. This is a critical role that requires strong leadership and management skills, as well as the ability to work effectively with various stakeholders.Key ResponsibilitiesMaintain facilities...
-
Production Manager
4 weeks ago
Fremont, California, United States Air Liquide Full timeJob SummaryAir Liquide is seeking a highly skilled Production Manager to oversee the daily operations of our manufacturing facility. As a key member of our team, you will be responsible for ensuring the efficient production of high-quality products while maintaining a safe and healthy work environment.Key ResponsibilitiesSupervise and Coordinate Production...
-
HSE Operations Manager
1 month ago
Fremont, California, United States Gateway Recruiting, INC. Full timePlant HSE ManagerGateway Recruiting, INC. is seeking a proactive Plant HSE Manager to oversee our health, safety, and environmental initiatives. This position demands a skilled leader with a robust background in promoting safety protocols and ensuring adherence to industry regulations. The successful candidate will demonstrate a track record of executing HSE...
-
Senior Tax Manager
4 weeks ago
Fremont, California, United States Gotion Full timeAbout the RoleGotion, Inc. is a leading innovator in electric vehicle and energy storage technologies, with a strong presence in the global market. We are seeking a highly skilled Tax Manager to join our team and lead our corporate tax function.Key ResponsibilitiesDevelop and implement global tax planning strategies to minimize tax expense and eliminate tax...
-
Senior Tax Manager
2 weeks ago
Fremont, California, United States Lam Research Full timeJob SummaryLam Research is seeking a highly skilled Senior Tax Manager to join our Tax Team. As a key member of our team, you will be responsible for managing the preparation and filing of U.S. federal and state corporate income tax returns, ensuring full compliance with applicable tax laws and regulations.Key ResponsibilitiesLead the preparation and filing...
-
Facilities Operations Manager
3 weeks ago
Fremont, California, United States Compass Group USA Full timeAbout the RoleWe are seeking a highly skilled and experienced Facilities Operations Manager to join our team at Compass Group USA. As a key member of our operations team, you will be responsible for overseeing the maintenance and upkeep of our facilities, ensuring they meet the highest standards of safety and efficiency.Key ResponsibilitiesMaintain...