Associate Director, Quality Assurance Support

Novo Nordisk; Clayton (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Paid time off

Health/dental/vision insurance

401K with company match

Parental leave

Product access

Tuition assistance

Life & disability insurance

Referral program

Employee discount

Job summary

Novo Nordisk in Clayton, NC is seeking a senior leader to head the QA Support department, aligning with the Novo Nordisk Way while ensuring compliance with applicable regulations and SOPs. This role drives process improvements and champions high-performance teams in a fast-paced manufacturing environment.

You will report to the Vice President of Quality Assurance, develop people via IDPs and annual goals, and partner across functions to exceed quality objectives.

Qualifications

• Bachelor's Degree in Life Sciences, Engineering or related field.
• Seven or more years of leadership experience.
• Eight or more years in the pharmaceutical industry, preferably with finished production processes of devices and combination products.
• Knowledge of US/EU regulations & GMPs preferred.
• CQE/CQA certifications preferred.

Responsibilities

• Lead the QA Support department according to PS Leadership competences; ensure compliance with regulations and procedures.
• Set targets and provide performance management; prioritize tasks.
• Improve productivity through efficient processes and develop employees.
• Lead cross-functional collaboration and support Regulatory inspections and internal audits.
• Backup for Vice President of Quality.

Skills

Leadership

Regulatory knowledge

GMP knowledge

Quality systems

Mentoring & development

Project management

Communication

Change management

Education

Bachelor's Degree in Life Sciences/Engineering

Job description

About The Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

About The Department
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic \"fill and finish\" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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 leading the QA Support department to ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Leads initiatives to drive process improvements within respective department.

Relationships

Reports to Vice President, Quality Assurance.

Essential Functions

• Responsible for leading the QA Support department according to PS Leadership competences, including:
• Maintaining compliance with applicable regulations & procedures
• Target setting & follow-up (performance management)
• Prioritization of tasks
• Improvement of productivity through efficient processes
• Development of employees
• Effectively lead through others as a second-line leader
• Driving high performance & employee engagement
• Contributing to the site Quality Management team by participation in strategy development
• Ensuring robust processes are in place to exceed all quality objectives & requirements
• Championing Continuous Improvement processes in the team
• Promoting positive collaboration with internal & external stakeholders
• Participation in regulatory inspections & internal audits
• Backup for Vice President of Quality
• 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

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

• Bachelor\'s Degree in Life Sciences, Engineering or related field required
• Minimum of seven (7) years of leadership (direct or indirect) experience.
• Minimum of eight (8) years of experience in the pharmaceutical industry, preferably with experience in finished production processes of devices and combination products
• Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP’s preferred
• Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10) preferred
• Excellent written & oral communication skills preferred
• Exercises good judgment in decision-making preferred
• CQA, CMQ/OE, &/or CQE certification preferred
• Demonstrated knowledge of cLEAN® preferred
• Proven expertise in mentoring & development, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross-functional teams required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.