About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world’s leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?

The Position

This position is primarily responsible for overseeing a team of QA Specialists ensuring the tactical execution of the internal and external (CMO) change control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for supporting other processes in the Novo Nordisk Quality Management System as well as driving continuous improvement projects within the department and/or in collaboration with global colleagues.

Relationships

Reports to the Director, Quality Assurance. Regularly interfaces with multiple NN global Quality departments and Contract Manufacturing Organizations (CMO). Drives and maintains a positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. frequent interactions with NN vendors throughout the GMP drug substance and drug product manufacturing process as well as through other functions and routine networking opportunities.

Essential Functions

• Change Control:
  • Develops and maintains the Change Control process covering NN Boulder in alignment with global requirements
  • Develops comprehensive, relevant resources (e.g. training program, FAQs) to enable compliance to change control process requirements across NN Boulder
  • Develops and leverages relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global health authority and/or stakeholder requirements
  • Acts in role as primary process SME for the Change Control process at NN Boulder
  • Support internal and external (CMO) stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations
  • Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and disposition of submitted change requests in the NN system
  • Provides SME support to direct reports and other employees working within the change control process, including consultation on in-process change requests
  • Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance
• Deviations:
  • Acts in role of primary process SME for the Deviation process at NN Boulder
  • Support direct reports as well as internal and external (CMO) stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations
  • Develops and leverages relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with local authority and/or stakeholder requirements
  • Acts in role of Quality Assurance for NN Deviation process, including review and disposition of submitted deviations in the NN system
  • Provides SME support to direct reports and other employees working within the deviation process, including consultation on in-process deviations
  • May assist in the coordination and/or execution of training activities relative to the Deviation process, including scheduling of training, monitoring execution, and ensuring sufficient resources are available in Line of Business areas to support the process
  • Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance

• System Management:
  • Acts as SME and local Super User for NN systems, specifically for the Change Control and Deviation modules. Includes participation in relative governance bodies e.g. Change Advisory Boards
• Quality Assurance:
  • Provides secondary support to all NN GxP Support processes, including but not limited to Document Management and/or Audits and Inspections, as necessary
  • Provide guidance and/or training to less experienced professionals or support staff
  • Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs. Leverage direct manager for support on as-needed basis

Physical Requirements

0-10% overnight travel required.

Qualifications

• Bachelor’s degree required; relevant experience may be substituted for degree, when appropriate; advanced degree preferred
• Requires a minimum of 8 years of progressively responsible related experience, with at least 4 years in area of specialty; pharma experience preferred
• Excellent interpersonal skills and ability to interact with staff on all levels
• Demonstrated ability to work independently without appreciable direction; typically receives oversight and direction only during critical decision points or issues
• Capability to identify and resolve moderately complex problems that require reviewing multiple factors to determine a resolution, with management support as needed
• Demonstrated problem solving skills, creativity, and initiative

***Please note we are open to hiring at senior Manager title commensurate with 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.

The base compensation range for this position is $121,050 to $211,840. 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 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.

The job posting is anticipated to close on 05/27/2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.

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.