Senior Manager - North America Operations Quality PV Oversight

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

Developing quality and strategic objectives and strong business understanding of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management. This role fulfills the PV Oversight function in PV deviation management processes, as well as providing SME-level input from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the covered processes. Communicate direction on a range of uniquely complex issues in a simple and understandable manner to i.e. team members.

Relationships

Reports to head of NAO Quality PV Oversight. Maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. Interacts closely with Marketing & Patient Solutions and NNI Patient Safety. External relationships include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage experienced quality representatives and/or contingency workers.

Essential Functions

• Deviation Management
  • Develops and serves as Quality Point of Contact for PV Deviation process covering NNI Patient Safety
  • Acts in the role of Deviation Responsible for NNI PV Deviation process, including the drafting of a deviation record with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform
  • Serve as chair of PV Deviation Board to facilitate the pre-approval review by board members of all NNI Patient Safety deviations to ensure alignment with NN requirements and external health authority regulations
  • Develops comprehensive, relevant resources (e.g. training program, FAQs) to enable compliance with Deviation process requirements across NNI and global as applicable
  • Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance within the scope of the Center of Excellence (COE)
  • Proactively identifies quality drift in NNI Patient Safety and NNI processes to mitigate deviation occurrence
  • Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations
  • Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering NNI
  • Provides SME support to employees working within the Deviation process, including consultation on in-process change requests within the scope of the COE
  • Develop and leverages relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global affiliate health authority and/or stakeholder requirements
  • Provides support to NAO Quality processes including but not limited to internal audits and inspections
  • Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs
• System Management
  • Acts as SME for the current deviation management IT system, with specific focus on Deviation module
  • Participate in relevant governance bodies e.g. Core Process Groups

Physical Requirements

Approximately 10% overnight domestic and/or international travel.

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

• Education Level
  • Bachelor’s degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred
• Experience Level
  • Requires 8+ years of progressively responsible related experience, with at least 4 years in area of specialty (deviation management); pharma experience preferred

• Specific or technical job skills
  • Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred
  • Excellent interpersonal skills and ability to interact with staff across all levels
  • Demonstrated ability to work independently without appreciable direction
  • Capability to identify, evaluate, and resolve complex issues that require reviewing multiple factors to determine proper resolution, with management support as needed
  • Demonstrated problem solving skills, creativity, and initiative
  • Managerial experience (if applicable): Experience managing others is a plus

The base compensation range for this position is $170,000 to $200,000. 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 and or company vehicles 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. 

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.