Associate Director, Quality Assurance Support

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Novo Nordisk's PS AM site in Clayton, NC is seeking a Senior QA leader to head the QA Support department, ensuring compliance with regulations and SOPs while driving process improvements. The role leads a second-line team and partners with cross-functional stakeholders.

As part of our Quality Assurance organization, you will mentor staff, set performance targets, participate in regulatory inspections, and contribute to site quality strategy and continuous improvement initiatives to deliver safe,

Qualifications

• Bachelor's degree in life sciences, engineering or related field.
• Minimum seven years of leadership experience (direct or indirect).
• Minimum eight years in pharmaceutical industry with finished production processes of devices and combination products.
• Strong knowledge of US/EU regulations and GMP applicability.
• Knowledge of Pharmaceutical Quality Systems (ICH Q10) preferred.
• Excellent written and oral communication skills.
• Certification in CQ/CMQ/OE/CQE preferred.
• Lean knowledge (LEAN) preferred.
• Proven mentoring, development and cross-functional leadership abilities.

Responsibilities

• Lead the QA Support department according to PS Leadership competences.
• Maintain compliance with applicable regulations and procedures.
• Set targets and monitor performance (performance management).
• Prioritize tasks and drive productivity improvements.
• Develop employees and coach through others as a second-line leader.
• Drive high performance and employee engagement.
• Contribute to site Quality Management team and strategy development.
• Ensure robust processes to meet quality objectives and requirements.
• Champion Continuous Improvement within the team.
• Promote collaboration with internal and external stakeholders.
• Participate in regulatory inspections and internal audits.
• Provide backup for Vice President of Quality.

Skills

Leadership experience

Regulatory knowledge (US/EU GMP)

Quality Systems knowledge (ICH Q10)

Communication skills

Mentoring & development

Change management

Planning & organizing

Education

Bachelor's Degree in Life Sciences, Engineering or related field

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.

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 14weeks 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-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.