Vice President - Quality Assurance

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential? The Position This position is responsible for leading the Quality culture with the BRD API US management team that meets the Novo Nordisk Quality Policy, QMS, and Quality objectives at BRD API US. Directs and coordinates the activities of Quality Assurance to support the production of BRD products through quality assurance programs which meet or exceed business, regulatory, and customer requirements in accordance with the Novo Nordisk Way. Formulate, communicate, and implement corporate strategy that effectively supports the manufacture of BRD products through quality assurance programs that ensure safe, effective, and pure products. Key Accountable Areas: This position is responsible for leading the strategic and tactical activities for Quality Assurance, Quality Systems, and Quality Compliance, at BRD API US. Responsible to manage areas above via subordinate management by setting direction, following up to ensure progress and goal attainment, and to provide feedback and coaching. A high level of innovation and collaboration is expected to continuously improve QMS processes and achieve improved quality at BRD API US. Essential Functions

Execute Novo Nordisk Quality System at Site NH to ensure that products are designed, manufactured, and shipped to customers such that quality, safety, and effectiveness are assured

Execute procedures and criteria for the release of product and distribution of production

Formulate, communicate, and implement corporate and local strategies that effectively supports the manufacturing of BRD products through quality assurance programs to ensure safe, effective, and pure products

Maintain an accurate and up-to-date knowledge of international and national standards and guidelines in Site NH’s area of activity

Responsible to lead, develop, and recruit a highly effective staff of appropriate technical depth to support current needs and future growth Site NH:

Ensure that current rules and regulations are complied with within BRD API US and the marketing authorization is kept. Responsible for quality assurance of all aspects of production of API products at BRD API US: Control and status assignment of API products

QA management responsible for process validations of products produced for market

Assure appropriate approval of all GMP documents and documentation in the department

Participation in building and re-building projects in the departments

Provide GMP education and communicate Quality Mindset

Principal respondent to Health Authority audits at BRD API US

Plan and ensure professional execution of inspections

As member of the management team in BRD QA and BRD API US:

Ensure a high level of quality in BRD API US

Always communicate Quality Mindset

Support BRD API US management team in follow up on quality KPIs, QMR, inspections, etc.

Ensure compliance in own department

Direct and manage quality management team which includes but is not limited to the following:

Set objectives for the department

Assure that the department meets goals and KPI’s in the area

Strategic planning for the department

Organizational planning and objective setting

Policy development

Assure that the department builds up and maintains working procedures and systems to assure

cGMP compliance and good housekeeping

High quality of work in all ways

Effective and flexible case handling

Recruitment/selection

Personnel training and development

General management according to NNWay

Assure development of employees

Assure that employees in the department are trained and motivated according to NNs visions and goals

Maintaining a healthy and engaging working environment in the department

Assure manning and back-up for key personnel

Define and follow-up budget for the department

Assure implementation and comply with cLEAN (including continuous process improvements via cLEAN methodologies)

Assure that all relevant HR activities are executed

As member of BRD API US management team, responsible to participate in setting goals, objectives, policy, and continuous improvement projects

Personnel and budget responsibilities for BRD API US QA

Assure planning and optimal use of resources in the department

Follow all safety and environmental requirements in the performance of duties

Perform other duties as assigned

Assures all activities comply with established company policies and perform all duties in compliance with global regulatory requirements, the NN Quality Manual and SOPs

Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes

Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Other individual assignments

Chairs the QMT forum for BRD API US

Physical Requirements

10-20% overnight travel required. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to grasp and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. Lifting up to 10 pounds of force occasionally. Visual acuity to perform close activities such as: reading, writing, and analysing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations.

Development of People

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 Degree in science, engineering, MS/MSC is preferred

Minimum twelve (12) years’ experience in pharmaceutical quality, manufacturing, or a related area

Minimum seven (7) years’ supervisory/management experience in pharmaceutical industry

A minimum of five (5) years’ experience in a licensed drug, device, or biologic facility regulated by FDA, EMEA or a leading international agency in a quality role

Exceptional communication skills and the proven ability to integrate into a team and manage complex projects

Strong computer skills

Strong presentation skills

Strong planning and organizational skills, and flexibility to change work priorities as necessary

Must have practical experience in working with the U.S. and international requirements for biologicals and/or pharmaceuticals

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.