Novo Nordisk
Compliance Manager - Cell Therapy Manufacturing
Novo Nordisk, Fremont, California, us, 94537
About the Department
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure. Are you ready to make a difference?
The Position
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research in cell therapy which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.
The Compliance Manager will ensure that manufacturing processes are executed in compliance with regulations and standards. i.e ATMP, 21CFR, 210, 211, 600, 610, ICH, cGMP, ISO, and Corporate/local SOPs and MBRs. The Compliance Manager is responsible for driving cGMP quality improvements and leading complex investigations on manufacturing quality events.
Relationships
The Compliance Manager is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Manager will report to a member of the Cell Therapy Leadership Team. Internal stakeholders include Cell Therapy in Novo Nordisk A/S (Denmark), Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.
Essential Functions
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 but not limited to 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 by going to the production areas for data gathering, observing of processes for investigations, and conducting associate interviews. Generate fishbone diagrams, and 5 Whys to establish root cause of deviations. Initiate appropriate corrective actions to prevent recurrence.
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. Provide updates to leadership on status of quality events.
Author, revise and review controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
Lead activities for audits and inspection readiness. Represent manufacturing in internal and external audits, and address audit findings. Collaborate with stakeholders to address compliance gaps identified in audits and inspections
Provide periodic review of department documentation and records such as logbooks, SOPs, etc. to assess for compliance with internal and regulatory requirements, established quality standards, policies, and procedures.
Stay updated on relevant regulations and guidelines in the cell therapy manufacturing industry, review and interpret regulatory requirements to ensure compliance in manufacturing processes
Physical Requirements
Up to 10% overnight travel required.
Qualifications
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. This encompasses leading peers and collaborating in cross-functional teams.
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.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The base compensation range for this position is $121,050 to $190,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure. Are you ready to make a difference?
The Position
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research in cell therapy which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.
The Compliance Manager will ensure that manufacturing processes are executed in compliance with regulations and standards. i.e ATMP, 21CFR, 210, 211, 600, 610, ICH, cGMP, ISO, and Corporate/local SOPs and MBRs. The Compliance Manager is responsible for driving cGMP quality improvements and leading complex investigations on manufacturing quality events.
Relationships
The Compliance Manager is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Manager will report to a member of the Cell Therapy Leadership Team. Internal stakeholders include Cell Therapy in Novo Nordisk A/S (Denmark), Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.
Essential Functions
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 but not limited to 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 by going to the production areas for data gathering, observing of processes for investigations, and conducting associate interviews. Generate fishbone diagrams, and 5 Whys to establish root cause of deviations. Initiate appropriate corrective actions to prevent recurrence.
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. Provide updates to leadership on status of quality events.
Author, revise and review controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
Lead activities for audits and inspection readiness. Represent manufacturing in internal and external audits, and address audit findings. Collaborate with stakeholders to address compliance gaps identified in audits and inspections
Provide periodic review of department documentation and records such as logbooks, SOPs, etc. to assess for compliance with internal and regulatory requirements, established quality standards, policies, and procedures.
Stay updated on relevant regulations and guidelines in the cell therapy manufacturing industry, review and interpret regulatory requirements to ensure compliance in manufacturing processes
Physical Requirements
Up to 10% overnight travel required.
Qualifications
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. This encompasses leading peers and collaborating in cross-functional teams.
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.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The base compensation range for this position is $121,050 to $190,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.