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Manufacturing Compliance Lead

Employer
Novo Nordisk
Location
Fremont, CA
Start date
Feb 14, 2024

Job Details

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
The Manufacturing Compliance Lead is responsible for driving cGMP quality improvements and leading complex investigations on manufacturing quality events. This position is an individual contributor role that works cross-functionally to ensure compliance with regulations, ISO standards & corporate/local SOPs.

 

Relationships

The Lead is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Lead 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

  • Develop metrics & analyze trends for Quality System process improvements, SPS, deviations & CAPA investigations.
  • 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.
  • Facilitate and participate in meetings, aligning internal review teams and area subject matter experts on an agreed upon investigational path forward.
  • Work closely with Manufacturing Managers to review and evaluate quality event information and trends. Participate in management meetings to update 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.
  • Actively engage in audit and inspection readiness activities. Participates in internal and external audits, and address audit findings.
  • Provide periodic review of department documentation and records such as logbooks, SOPs, etc. to assess for compliance with regulatory requirements, established quality standards, policies, and procedures.
  • Maintain knowledge of current good manufacturing practices (cGMPs) and regulatory requirements, and proactively ensure manufacturing teams incorporate and adhere to regulatory and corporate requirements.  

 

Physical Requirements

0-10% overnight travel required. Ability to qualify to work in the cleanroom, up to Grade A requirements. Ability to lift 25 lbs. Ability to work outside of normal working hours as required to process the cells.

 

Qualifications

  • Education Level: BS or AS in a life sciences field
  • Experience Level: BS with 10+ years or AS with 12+ years of experience of relevant experience. Advanced degree may be substituted for experience as appropriate
  • 10+ years of GMP, QA &/or related experience in the pharmaceutical or medical device, or related industry with progressively increasing responsibility.
  •  Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner.
  • Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing.
  • Demonstrated skills in conflict resolution, problem solving in a cross functional setting, with the ability to keep the meeting on track to achieve objectives.
  • Must have the ability to work in a fast-paced environment, with the ability to manage multiple projects and objectives for on-time event closure.
  • Must be proactive, detail-oriented, and can adapt to change.
  • Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects.
  • Ability to understand and apply cGMP regulations as they relate to manufacturing.
  • Ability to operate efficiently in a complex matrix organization and global environment.
  • Strong computer skills, including efficiency using Microsoft Office (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
     

 

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 $98,000 to $136,000. This range is part of a family of roles and this role can be leveled up commiserate with experience. 

 

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.

Company

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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Company info
Website
Phone
617-612-6200
Location
75 Hayden Avenue
Lexington
MA
02421
United States

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