Director - Quality Management Systems

About the Department   

As a part of Novo Nordisk’s Strategy and Rare Disease organization, the Forma team is focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Its R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Forma’s Pharm Sci and QA team is focused on activities supporting clinical supply chain, drug formulation & manufacturing, and GMP, GCP, auditing in support of Sickle Cell Disease (SCD) programs. We’re looking for individuals who are enterprise thinkers, inclusive leaders, and strong collaborators, as we embark on shaping our future. Are you ready to make a difference?

The Position

This role is essential to ensure coordination and integration of the Forma QMS with the Novo Nordisk QMS. The person will be responsible for establishing working relationships across functional areas and ensuring appropriate documents and training exist for support of GxP work.

Relationship

Reports to The Head of Quality at the Watertown, MA site. The successful candidate will interact with Novo Nordisk colleagues in Quality Systems, GMP, and GCP in Watertown, Lexington MA, and Denmark. The job includes responsibility for managing two contract employees.

Essential Functions

• Oversight of Veeva eQMS administration and management:
  • Direct contract employees in their daily assignments such as granting access to the system, providing training, following up on pending or overdue tasks, etc.
  • Periodically review reports/dashboards to identify any areas of non-compliance that must be addressed
• Management of training assignments and compliance
  • Ensure direct reports are assigning training appropriately, and that assigned training is completed
  • Periodically review reports/dashboards to identify any areas of non-compliance that must be addressed

• Input to larger change request cases being drafted by colleagues working within the Novo Nordisk QMS
  • Meet with NN colleagues to provide necessary information for creating change requests
  • Participate in QA integration working group, and ensure assigned tasks are completed
• Oversee essential QMS functions
  • Periodically review reports/dashboards to identify any areas of non-compliance that must be addressed, including Deviations, Investigations, Change Controls, CAPAs, and effectiveness checks

• Own Quality Management Review process
  • Work with QA team at Watertown and in Denmark to ensure necessary key performance indicators are tracked, trended and provided at regular intervals for QA management review
  • Adjust the Forma Quality Management Review (QMR) process to meet requirements for NN QMR
  • Schedule and execute periodic QMRs in compliance with requirements

Physical Requirements

Approximately 5% overnight travel, domestic/international.

Development of People

Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Bachelor's or more advanced degree in a scientific discipline or equivalent experience
• 10+ years of overall relevant job experience;
• 7+ years of experience in the biotech and/or pharma industry
• 5+ years of experience related to Quality Systems activities
• Required:
  • Prior experience managing personnel
  • Thorough working knowledge of GxP Quality Systems
  • Strong understanding of relevant GxP regulations, guidelines, and guidances
  • Working knowledge of software solutions for QMS
  • Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment
  • Strong project management skills with an emphasis on critical thinking and problem solving
  • Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance

• Preferred:
  • Previous GMP QA operations experience (batch record review, lot release, etc.) strongly preferred
  • Experience implementing and validating electronic systems and understanding of 21 CFR 11 requirements and/or GAMP5
  • Familiarity with data integrity controls
    • Veeva QMS experience

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.

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.