Associate VP, Drug Product Manufacturing US Quality

Initial Therapeutics, Inc.

Clayton (NC)

On-site

USD 180,000 - 240,000

Full time

7 days ago
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Benefits offered by this job

Annual bonus
Paid holidays
Health insurance
Dental insurance
Vision insurance
401K match
Parental leave
Tuition assistance
Life & disability
Employee referrals

Job summary

Novo Nordisk is seeking an Associate Vice President of Drug Product Manufacturing US Quality to lead the quality organization across Clayton, Bloomington, and Durham, ensuring testing and quality programs meet business and regulatory requirements.

You will formulate corporate and local strategies, oversee a 300+ employee team, and drive programs that ensure product safety and regulatory compliance, partnering with senior leadership to deliver quality at scale.

Qualifications

  • Bachelor's degree required in science, engineering, business or related field.
  • Master’s degree preferred.
  • Minimum of ten years in pharmaceutical quality/manufacturing or related area.
  • Minimum of five years of supervisory/management experience in pharmaceutical industry.

Responsibilities

  • Head up DPM US Quality across Clayton, Bloomington and Durham sites.
  • Formulate, communicate and implement corporate/local quality strategies to ensure patient safety.
  • Direct and manage the quality management team and related activities.
  • Provide training and development; lead performance and succession planning.
  • Oversee recruitment/selection, employee relations, and budget management.
  • Drive continuous process improvement via cLEAN methodologies.
  • Ensure policy development complies with safety/environmental requirements.

Skills

Written and verbal communication
Presentation skills
FDA regulations knowledge

Education

Bachelor's Degree in science/engineering/business
Master’s Degree

Job description

About the Department

At Novo, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo 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

The Associate Vice President of Drug Product Manufacturing US Quality (DPM US Quality) will head up the Quality Assurance organization across the DPM Manufacturing sites in Bloomington Clayton and Site Durham. Direct and coordinate the activities of the DPM US Quality organization to support the production of Novo’s products and devices through testing and quality assurance programs which meet or exceed business, regulatory and customer requirements in accordance with the Novo Way. Formulate, communicate and implement the corporate strategy that effectively supports the manufacture of Novo products through testing and quality assurance programs that ensure patient safety. RelationshipsThe position reports to the Senior Vice President of Manufacturing Quality and is a member of the Manufacturing Quality Management team. The incumbent will be responsible for the entire organisation consisting of 5 direct reports and a total of 300 + employees. In addition, the Associate Vice President will be a part of the DPM USManagement team.

Essential Functions
  • Head up DPM US Quality ensuring that the organization is a strong partner to Line of Business
  • Formulate, communicate and implement the corporate and local strategies that effectively supports the manufacturing of Novo products to ensure patient safety
  • Direct and manage quality management team which includes but is not limited to the following:
  • Training and development
  • Performance leadership
  • Recruitment/ selection
  • Employee relations
  • Budget
  • Continuous process improvement via cLEAN methodologies
  • Organizational planning and objective setting
  • Policy development follows all safety and environmental requirements in the performance of duties
  • Perform 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 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´s policies, procedures and Novo Way.

Qualifications
  • Bachelor's Degree in science, engineering, business, or related field of study from an accredited university required and a minimum of ten (10) years of experience in pharmaceutical quality, manufacturing or a related area required
  • Master’s Degree preferred
  • Minimum of five (5) years of supervisory/management experience in pharmaceutical industry required
  • Excellent written and verbal communication skills required
  • Strong presentation skills required
  • Excellent working knowledge of FDA regulations relevant to the business 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.

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