Manager, Validation & Proc Spt

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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 12 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

Manage all project activities & personnel related to the procurement, qualification, implementation & maintenance of processes, equipment & utilities for the Site. Provide comprehensive validation subject matter expertise. Establish & maintain good communication & working relationship with stakeholders. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way.

 

Relationships

Senior Manager.

 

Essential Functions

• Maintain plans to meet changes in customer requirements
• Implement projects & evolve the science and risk-based validation program for the Site in accordance with NN procedures & local requirements
• Develop Site processes and lifecycle management in accordance with NN procedures & local requirements
• Champion for GMP compliance to ensure 21 CFR part 11 compliance of all computer systems
• Empower team to successfully execute projects & deliver during the verification process
• Build and develop a strong high performing cross-functional team
• Develop relationships with Novo Nordisk project organization & validation project contributors (local & abroad)
• Collaborate with Site Leadership on workload solutions & advocate for project and resource prioritization
• Frequent planning to ensure resources are in place to execute according to plan
• Ensure tracking & reporting of KPI’s
• Ensure clear and essential communication with customers, ensure alignment with ET OFP DK & all other relevant stakeholders
• Responsible for ensuring department documents are current & standardized
• Define user requirements & ensure correct & clear validation & verification activities
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

 

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role).

 

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 engineering, chemistry, biological sciences, or related field of study from an accredited university required
• Master’s degree in pharmaceutical, engineering, or other technical sc