Manager - North America Operations Quality PV Oversight

About

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

This position reports to the Head of Pharmacovigilance (PV) Oversight and/or Head of NAO Quality and is an individual contributor role.

Position is responsible for developing Quality and NAO strategic objectives and strong business understanding of the value chain and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients.

Additionally, this role will drive continuous improvement projects within the department, affiliate and/or in collaboration with global colleagues, while stiving for simplicity and ensuring adherence to regulations and requirement.

Relationships

Role will manage multiple internal relationships with personnel at all levels of the business, and other functional groups across Novo Nordisk, locally and globally. This position will also have interactions with key external stakeholders including global and local vendors, health authority representatives and industry peers through industry membership networking.

Individual will also serve as a Quality Business Partner driving value creation and linking quality to business by supporting relevant functional areas in NNI with their Must Win Battles and key business decisions.

Essential Functions

• Develop and ensure that the QMS is aligned, maintained, and in compliance with local/global set-up and internal/external requirements
• Acts as subject matter expert to support relevant enterprise stakeholders in the management of deviation handling in Good Pharmacovigilance Practice (GVP) inclusive of robust root cause analysis (RCA) and corrective and preventative actions (CAPA) authorship
• Supports and maintains continuous oversight on timely completion of all deviation related actions according to defined timelines (corrections, corrective, preventative actions, and effectiveness checks)
• Ensures timely escalation of business-critical issues, to NAO Quality Management
• Support and advise stakeholders when questions/issues/situations related to PV related matters arise by investigating, researching, and providing recommendations or solutions to mitigate or resolve
• Promote knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization
• Maintains up-to-date knowledge of relevant industry standards and PV regulations, and company policies and procedures relevant to area of work
• Ensure continuous improvement and alignment of the QMS to meet both local and global project needs, while supporting quality-driven initiatives across the organization
• Support audits and Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations
• Function as a quality partner/resource promoting knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization
• Support, coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) (CAPA) in connection with audit and/or inspection responses, and ensure proper implementation across various areas of the business
• Continuously assess and identify quality gaps across the business and actively drive projects focused on addressing the gap
• Monitor and escalate business-critical PV compliance signals/external requirements and issues to NAO Quality management
• Support the process for the delivery of functional metrics to external stakeholders as well as NAO Quality Management
• Provides support to other segments of NAO Quality as requested by management
  
  
  

Physical Requirements

0-20% overnight travel required. International travel may be required.

Qualifications

• A Bachelor's degree required (in science-related discipline preferred); relevant experience may be substituted for degree, when appropriate
• Requires a minimum of 5 years of progressively responsible related PV experience, with at least 3 years in area of specialty; pharma experience preferred
• A minimum of 3 years in area of specialty (e.g., Deviation Handling) pharma experience preferred
• Advanced knowledge of deviation handling processes inclusive of performing robust root cause analysis (RCA) and CAPA management
• Proficient knowledge of Good Pharmcovigilance Practice (GVP), federal and local regulations, research process and scientific knowledge as it relates to PV processes through understanding of NN Standard Operating Procedures (SOP)
• Demonstrated ability to work independently with limited management oversight; typically receives oversight and direction only during critical decision points or issues
• Excellent interpersonal skills and ability to interact with staff on all levels
• Proficient in identifying and resolving complex problems that require reviewing multiple factors to determine a resolution, with minimal management oversight
• Demonstrated excellent problem-solving skills, creativity, and initiative
  
  
  

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.