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    Manager, Quality Management Systems Api

    Novo Nordisk
    7-10 years
    Not Disclosed
    Durham Remote United States
    10 Feb. 13, 2025
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Manager, Quality Management Systems API
    Location: Clayton, United States
    Job Category: Quality

    The Position

    The Manager of Quality Management Systems (QMS) is responsible for leading the DAPI-US QMS department and fulfilling the department’s targets in alignment with the Novo Nordisk Way. This position will oversee all quality management systems at DAPI US.

    Relationships

    • Reports to: Vice President, Quality

    Essential Functions

    • Leadership & Performance Management:

      • Lead the QMS department according to PS Leadership competencies, ensuring compliance with applicable regulations and procedures.
      • Set and follow up on departmental performance targets.
      • Prioritize tasks effectively and improve productivity through efficient processes.
      • Drive employee development and ensure high performance and engagement within the team.
      • Collaborate with internal and external stakeholders, including customers, to meet departmental goals.

    • Quality Management System (QMS):

      • Contribute to strategy development and execution of cLEAN® activities within the site’s Quality Management team.
      • Build and implement the QMS from project phase to operational processes.
      • Ensure effective local site support for Regulatory Affairs (RA), including site Annual Product Reviews (APRs).
      • Oversee compliance with Documentation & Records Management.
      • Provide coaching and support for Quality Assurance teams regarding QMS deployment and regulatory compliance.

    • Training & Development:

      • Ensure the execution of GMP and Quality Training programs in collaboration with P&O.

    • Additional Duties:

      • Perform other duties as assigned.

    Physical Requirements

    • Ability to work in an open office environment with potential for frequent distractions.
    • Ability to travel up to 10% of the time (travel percentage may vary based on the role).

    Development of People

    • Supervisory Responsibilities:
      • Ensure all reporting personnel have Individual Development Plans (IDPs) with annual goals and measurements aligned with business priorities.
      • Hold interim reviews to ensure work is focused on priorities and provide feedback on accountability and progress.
      • Ensure completed learning and aspiration plans are included in IDPs to support employees’ growth and readiness for more responsibility.
      • Oversee the application and communication of all Novo Nordisk policies, procedures, and the Novo Nordisk Way.

    Qualifications

    Education/Experience:

    • Required:

      • Bachelor’s Degree in Life Sciences, Engineering, or related field.
      • Master’s Degree in Life Sciences, Engineering, or related field preferred.
      • 7-10 years of experience in the pharmaceutical industry, preferably in Aseptic Processing.
      • 2+ years of supervisory experience.
      • 2+ years of project management experience.
      • Expertise in US and EU regulations and GMP guidelines, including ISO standards.
      • Knowledge of Pharmaceutical Quality Systems (e.g., ICH Q10).

    • Preferred:

      • Excellent written and oral communication skills.
      • Strong computer skills in MS Office, MS Project, etc.
      • Certifications such as CQA, CMQ/OE, and/or CQE.
      • Knowledge of LEAN tools and training techniques for adult education.

    Behavioral Requirements

    • Strong decision-making skills and the ability to exercise good judgment.
    • Strong leadership skills, with a focus on driving high performance and engagement.

    Commitment to Diversity & Inclusion

    At Novo Nordisk, we strive to be the best company for the world, with a commitment to diversity, inclusion, and equal opportunity. We are dedicated to building an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.

    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 require special assistance or accommodations to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    This structured format makes it easy for candidates to navigate the key details of the role, responsibilities, qualifications, and company values.

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