Manager, AP Process & Compliance

BioSpace
Clayton, NC Full Time
POSTED ON 5/7/2024 CLOSED ON 5/30/2024

What are the responsibilities and job description for the Manager, AP Process & Compliance position at BioSpace?

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 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 legacy Injectable Finished Products (IFP) 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 IFP, 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 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

Leads tactical & long-term strategic activities to drive process & compliance improvement within AP & ensure process stability, quality robustness & standardization across shift teams.

Relationships

Director, Aseptic Production.

Essential Functions

  • Coaching & mentoring of direct reports in accordance with the NNWay essentials
  • Development of long-term process & quality improvement plans
  • Champion creation of simple & robust Quality standards & expectations
  • Drive quality process performance to meet business & customer needs
  • Championing the Quality Event Communication & Containment processes
  • Process confirmation & continuous improvement of NC Process & compliance standards
  • Identify trends proactively to drive & prioritize compliance improvement projects & initiatives
  • Process Group Responsibilities (non-Technical) representing the Clayton site & contributing globally to better / best practices & projects for manufacturing compliance & robustness
  • Audit team coordination & development of audit standards / practices
  • Ownership of AP APR coordination
  • Ownership of AP Customer complaint coordination
  • Ownership of procedural support for PS@SAP & Pas-X, & Serialization to include establishment of departmental roles & responsibilities for these systems
  • Ensure strong collaboration across departmental boundaries
  • 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, Science, Business or related field. MS preferred or industry equivalent experience preferred
  • Minimum 5 yrs. leadership / management experience in Manufacturing or Quality with a preference toward pharmaceutical or other regulated industries preferred
  • In depth knowledge of aseptic & inspection processes preferred
  • Knowledgeable in Quality Management System, Lean and/or Six Sigma methodologies preferred
  • Proven track record of implementing sustainable process improvements preferred
  • Proven expertise in planning / organizing, managing execution, checking results & revising strategic plans to ensure short & long term objectives are met preferred


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.
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