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    Senior Cgmp Investigator

    Novo Nordisk
    5+ years
    Not Disclosed
    Bloomington 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: Senior cGMP Investigator
    Location: Bloomington, United States
    Job Category: Quality

    The Position

    The Senior cGMP Investigator plays a key role in leading and managing deviation investigations within the quality department. This position focuses on troubleshooting, identifying root causes, and ensuring corrective and preventative actions (CAPAs) are implemented. The role requires proficiency in cGMP regulations, strong leadership skills, and the ability to drive complex investigations to closure while mentoring team members.

    Relationships

    • Reports to: Caleb Buuck

    Essential Functions

    • Deviation Investigations:

      • Lead multi-functional teams to troubleshoot and identify root causes of deviations.
      • Ensure deviation investigations align with company standards, including triage and Risk Priority Number (RPN) classification.
      • Review and address discrepancies in the classification with the Quality unit.
      • Develop and communicate the problem statement for investigations and engage SMEs to assess the scope.

    • Investigation and CAPA:

      • Conduct interviews and gather necessary data to aid in investigations and present findings clearly.
      • Develop a hypothesis framework and lead SMEs in driving down root causes.
      • Prioritize corrective actions based on engineering solutions before considering administrative controls.
      • Complete deviation reports detailing facts, evidence, and clear CAPAs.
      • Present draft investigations and CAPAs to the deviation review board for approval.
      • Develop and monitor CAPA effectiveness plans and follow up on repeat deviations.

    • Mentorship and Leadership:

      • Mentor investigators and provide expertise when needed.
      • Lead team meetings and huddles, ensuring timely closure of major deviations.
      • Ensure a minimum of 10 major deviations are completed per month.

    Physical Requirements

    • Frequent sitting, standing, walking, reading, and use of a computer.
    • Occasional stooping, kneeling, crouching, and carrying.
    • Must comply with Environmental Health and Safety (EHS) requirements.
    • Ability to work in a clean room environment, as needed.

    Qualifications

    Education/Experience:

    • Required:

      • Bachelor’s degree in a STEM discipline.
      • 5-8 years of experience in a GMP or regulated industry.
      • At least 2 years of experience in GMP.

    • Preferred:

      • Master’s degree or higher.

    Technical Skills:

    • Proficiency in Excel, Word, and other office software.
    • Experience with quality, operations, and scientific management software (TrackWise®, ComplianceWire®, JD Edwards®).
    • Ability to understand and apply cGMPs in clinical and commercial operations.
    • Familiarity with ICH, FDA, and EMA regulations.
    • Prior experience leading deviation investigations using root cause analysis tools.
    • Knowledge of change control, CAPA, and risk assessment tools (e.g., FMEA).

    Behavioral Requirements

    • Ability to communicate effectively in English and follow detailed instructions.
    • Strong time management and organizational skills.
    • Ability to cooperate in team environments and work independently.
    • Detail-oriented and able to handle high-pressure situations with multiple deadlines.
    • Ability to mentor and transfer knowledge to others.
    • Strong critical thinking and problem-solving skills.
    • Solution-oriented and persistent in overcoming obstacles to drive investigations to closure.
    • Strong leadership and team-building skills, with the ability to engage SMEs and stakeholders.
    • Excellent listening skills and the ability to gather relevant information from SMEs.

    Leadership Requirements

    • Lead by example in alignment with company values and culture.
    • Build strong relationships with peers and teams.
    • Take initiative for personal and professional development.
    • Act proactively to address changes in scope and procedural errors.
    • Establish trust and respect within the team and department.

    Commitment to Diversity & Inclusion

    At Novo Nordisk, we aspire to be the best company for the world by fostering an inclusive culture that values the diversity of our employees, patients, and communities. We are dedicated to creating a workplace where diverse perspectives are celebrated and everyone can thrive.

    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 provides clarity and focus, allowing potential applicants to better understand the essential responsibilities and qualifications for the Senior cGMP Investigator position.

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