Senior Manager -Quality Assurance USO

Novo Nordisk Quality Assurance Role

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare 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 US Operations (USO) 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 the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides 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.

Relationships

Reports to the Director, Quality Assurance. Interfaces with multiple NNA / S Quality departments and Quality departments in global affiliate offices. Drives and maintains a positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. interactions with NNI vendors during periodic auditing functions and routine networking through membership in industry association(s). This job is an individual contributor and does not have dotted line relationships or responsibilities for direct management of contingent workers.

Essential Functions

Deviation Management :

• Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system.
• Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Deviation process requirements.
• Execute regular surveillance, follow-up, and reporting program to ensure local process compliance.
• Acts in role as process SME for the Deviation process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.

Change Control :

Content Control :

Quality Assurance :

Physical Requirements

0-10% overnight travel required.

Qualifications

Education Level :

Experience Level :

Specific or technical job skills :

Compensation

The base compensation range for this position is $116,810-$216,100. 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.

Novo Nordisk Commitment

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. 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.