Operations Manager - US GCM

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.  At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.  

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance 
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.
 

The Position

Responsible for ensuring production quality standards, timely delivery, and release of products to our internal and external customers from Contract Manufacturing Organizations (CMOs) and/or Contract Manufacturers & Suppliers in operation. Represent Global Contract Manufacturing (GCM) focusing on US CMO's and/or Contract Manufacturers & Suppliers.

Relationships

Reports to Senior Manager.

Essential Functions

• Responsible for manufacturing, compliance, capacity, KPI reporting and follow up, and other related activities at the respective contract sites
• Build and maintain good and trustful relations with external stakeholders and internally supporting Novo Nordisk overall goals and strategy
• Securing timely communication to respective management regarding operational issues and critical cases
• Foster collaboration with internal and external stakeholders
• Drive continuous optimization of and improvements at the respective contract sites to drive performance and a Lean mindset
• Prepare and head meetings with external stakeholders, including but not limited to business review, operational and ad hoc meetings
• Have the overview and priority of all GCM operational Novo Nordisk activities at the respective contract sites
• Support the daily operation of respective external stakeholders in cooperation with QA and logistics, including handling and escalating issues
• Manage respective contract site related operational activities e.g., initiate Novo Nordisk Change Requests (CR), deviations, procedure (SOP) updates, projects, Novo Nordisk Annual Product Review/Product Quality Review, new product introduction, customer complaints, etc.
• Ensure terms of contracts with external stakeholders are implemented and upheld
• Participate in audits of respective contract sites and be audit finding owner, where applicable
• Ensure that respective contract site maintains the desired quality mindset and are in compliance with the necessary quality requirements at all times; collaborating with QA and the audit team when necessary
• Ensure that deviation handling is addressed with the right priority level and corrective action is being taken for addressing deviations and/or quality issues; collaborating with quality support team when necessary
• Follow all safety & environmental requirements in the performance of duties
• Other duties, as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 15% of the time.

Qualifications

• Bachelor’s degree in Engineering, Supply Chain, Pharmacy, or relevant field of study from an accredited university required
• Master’s degree in Engineering, Supply Chain, Pharmacy, or relevant field of study from an accredited university preferred
• Minimum of ten (10) years of experience in Supply Chain or Quality Assurance work in a manufacturing environment required, preferably in a pharmaceutical or medical device manufacturing environment
• Experience with current GMPs or regulated industries required
• Experience with medical devices including molding and assembly processes preferred
• Experience in working with CMO’s or contract manufacturers preferred
• Demonstrate action-oriented behaviours required
• Collaboration with colleagues & stakeholders across functions & departments required
• Work in structured manner & take ownership of assignments preferred
• Result-oriented & take pride in delivering on milestones required
• Motivate colleagues through positive, forthcoming attitude preferred
• Entrepreneurial decision making as if it was your own business plus
• Ability to communicate from operations level to CVP level required

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.