Regulatory Compliance Lead
2 days ago
About Novo Nordisk
Novo 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 Overview
The Compliance Manager plays a crucial role in ensuring that all manufacturing operations adhere to applicable regulations and standards, including ATMP, 21CFR, 210, 211, 600, 610, ICH, cGMP, ISO, and corporate/local SOPs and MBRs. This position is pivotal in driving quality enhancements and managing complex investigations related to manufacturing quality incidents.
Key Responsibilities
- Provide expert guidance and support to the manufacturing team to maintain compliance with regulatory and internal standards.
- Develop and implement training programs aimed at educating manufacturing staff on compliance protocols.
- Conduct thorough risk assessments to identify compliance deficiencies and formulate mitigation strategies.
- Lead systematic problem-solving initiatives for investigations, utilizing metrics and trends to enhance processes.
- Generate change controls and perform risk and impact assessments.
- Oversee and document manufacturing quality events, including deviations and change controls.
- Author and manage deviation reports, leading investigations to resolution.
- Employ problem-solving techniques, such as fishbone diagrams and 5 Whys, to determine root causes of deviations and initiate corrective actions.
- Facilitate meetings with internal review teams and subject matter experts to align on investigational strategies.
- Collaborate closely with the manufacturing team to analyze quality event data and provide leadership updates on quality status.
Documentation and Audits
- Author, revise, and review controlled documents (e.g., batch records, SOPs) to ensure compliance with cGMP standards.
- Lead audit and inspection readiness activities, representing manufacturing during internal and external audits, and addressing any findings.
- Conduct periodic reviews of departmental documentation to ensure adherence to established quality standards and regulatory requirements.
Qualifications
- Bachelor's degree preferred, ideally in a life sciences discipline, with a minimum of 7 years of relevant experience.
- An Associate degree is acceptable with 9+ years of experience in a controlled cell culture environment.
- At least three years of demonstrated leadership experience in compliance and continuous improvement within the biotechnology or pharmaceutical sectors.
- Proficient in writing compliance documentation, including investigations, deviations, and technical reports.
- Strong communication skills, capable of engaging with all organizational levels and cross-functional teams.
Work Environment
This role may require up to 10% overnight travel.
Commitment to Diversity
Novo Nordisk is committed to fostering an inclusive workplace that values diverse perspectives and backgrounds. We believe that a diverse workforce is essential to our mission of improving global health.
-
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...
-
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...
-
Global Regulatory Compliance Specialist
5 days ago
Fremont, California, United States Tesla Full timeJob Title: Global Regulatory Analyst, DemandsTesla is seeking an experienced professional to manage regulatory information requests and investigations globally. The ideal candidate will be responsible for developing and maintaining a database or tool for logging and monitoring the status of all regulatory investigations and requests for information from...
-
Global Regulatory Compliance Specialist
2 weeks ago
Fremont, California, United States Tesla Full timeJob Title: Global Regulatory Analyst, DemandsTesla is seeking an experienced professional to manage regulatory information requests and investigations globally.Key Responsibilities:Develop and maintain a database or tool for logging and monitoring status of all regulatory investigations and requests for information from regulators across the globe.Coordinate...
-
Regulatory Affairs Director
1 week ago
Fremont, California, United States Scribe Therapeutics Full timeJob Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is dedicated to developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...
-
Regulatory Affairs Specialist
1 day ago
Fremont, California, United States Yoh, A Day & Zimmermann Company Full timeJob Title: Regulatory Affairs Associate IYoh, a Day & Zimmermann company, is seeking a highly skilled Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.Responsibilities:Assist in preparing responses to global information...
-
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 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 ResponsibilitiesProvide guidance and support to the manufacturing team to ensure...
-
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...
-
Regulatory Affairs Specialist
2 weeks ago
Fremont, California, United States Infojini Consulting Full timeRegulatory Affairs SpecialistInfojini Consulting is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with EU IVD regulations.Key Responsibilities:Assist in the preparation of regulatory submissions for IVDR...
-
Fremont, California, United States Abbott Full timeAbout the RoleThis Senior International Regulatory Product Specialist will be part of the Diabetes Care Division at Abbott, working on-site at our Alameda, CA location. We're a leading healthcare company focused on helping people with diabetes manage their health with innovative products that provide accurate data to drive better-informed decisions.Key...
-
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...
-
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...
-
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...
-
Senior Regulatory Product Specialist
1 week ago
Fremont, California, United States Abbott Full timeThe OpportunityThis Senior International Regulatory Product Specialist will play a key role in the Diabetes Care Division at Abbott, working on-site at our Alameda, CA location. Our team is dedicated to helping people with diabetes manage their health with innovative products that provide accurate data for informed decisions. We're revolutionizing glucose...
-
Senior Regulatory Product Specialist
3 weeks ago
Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
-
Fremont, California, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior International Regulatory Product Specialist to join our Diabetes Care Division at Abbott. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our regulatory department.Key ResponsibilitiesAssist in the development and...
-
Principal Regulatory Affairs Specialist
2 weeks ago
Fremont, California, United States Abbott Full timeThe OpportunityAbbott is seeking a highly skilled Principal Regulatory Affairs Specialist to join our Diabetes Care Division in Alameda, CA. As a key member of our team, you will play a critical role in ensuring the regulatory compliance of our new product introductions in the US market.This is an exciting opportunity to work on breakthrough advancements in...
-
Internal Audit Lead, Quality Assurance
3 weeks ago
Fremont, California, United States Neuralink Full timeJob SummaryWe are seeking a highly skilled Internal Audit Lead, Quality to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.Key ResponsibilitiesConduct audits of GLP, GMP,...
-
Fremont, California, United States Neuralink Full timeJob SummaryWe are seeking a highly skilled Internal Audit Lead, Quality Assurance Specialist to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.Key ResponsibilitiesConduct...
-
Wireless Test Engineer
4 weeks ago
Fremont, California, United States TUV Rheinland of North America Full timeJob SummaryTUV Rheinland of North America is seeking a highly skilled Wireless Test Engineer to join our team. As a key member of our testing team, you will be responsible for conducting RF compliance testing and ensuring that wireless devices meet regulatory standards.Key ResponsibilitiesRF Compliance Testing: Conduct RF compliance testing to ensure that...