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    Senior Manager, Quality Compliance – Cgmp

    Jubilant Pharma
    5+ years
    Not Disclosed
    Remote
    10 Jan. 27, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 Manager, Quality Compliance – cGMP
    Location: Not specified in the job description
    Job Type: Full-time

    Company Overview:
    Jubilant Radiopharma, a leader in nuclear medicine, is committed to improving lives globally through the development, manufacturing, and distribution of high-quality diagnostic and therapeutic agents. We specialize in radiopharmaceuticals and offer cutting-edge solutions to advance the practice of nuclear medicine. Join our dynamic team and make a significant impact on patient care and outcomes.

    Job Description:
    We are seeking an experienced and dedicated Senior Manager, Quality Compliance – cGMP to manage the cGMP Compliance group and oversee all quality assurance and compliance activities within our manufacturing operations. The ideal candidate will have extensive experience in FDA regulations, cGMP compliance, and quality system management, with a focus on radiopharmaceuticals.

    Key Responsibilities:

    • Lead the cGMP Compliance team and provide indirect oversight of field operations team members responsible for Quality management in manufacturing operations.
    • Maintain an expert-level knowledge of FDA, USP, cGMP Quality System Standards, and other applicable regulations. Apply these regulations effectively to radiopharmaceuticals.
    • Identify and communicate risks and compliance gaps to Jubilant Radiopharma’s Quality management team.
    • Oversee FDA-related documentation, ensuring accuracy and adherence to FDA guidelines. Provide oversight of consultant staff, ensuring their work meets both internal Jubilant standards and FDA submission requirements.
    • Develop, manage, and lead the cGMP compliance program and Quality System for all Jubilant Radiopharma manufacturing facilities.
    • Develop and present training materials to ensure operational team members are compliant with cGMP regulations and quality standards.
    • Act as a key representative in audits, ensuring effective preparation for FDA and third-party audits.
    • Lead and manage quality investigations, CAPA (Corrective and Preventive Action) processes, and provide resolutions to any non-conformances.

    Qualifications:

    • Education: Bachelor’s degree in Life Sciences, Pharmaceutical Science, or related field (or equivalent work experience).
    • Experience:
      • At least three (3) years of experience in cGMP pharmaceutical/biotech/PET operations.
      • Minimum of five (5) years experience in FDA cGMP regulations, including validation, process design, change control, document management, and audit responses.
      • Experience in the FDA validation process, writing effective SOPs, and handling audits.
      • Knowledge of PET radiopharmaceutical production and relevant regulatory applications is preferred.
      • Expert-level knowledge of requirements for software, equipment, and process validation.
      • Proven ability to manage and lead a team, prioritize tasks, and work independently.
      • Strong problem-solving abilities, sound judgment, and a results-driven approach.

    What We Offer:

    • Competitive salary
    • Career growth and development opportunities
    • Supportive work culture
    • Medical, dental, and vision benefits
    • 401(k) with company matching
    • Paid Time Off (PTO) and paid holidays
    • Short- and long-term disability coverage

    How to Apply:
    Qualified candidates are encouraged to apply by clicking the "apply" button. For individuals with disabilities needing assistance in applying, please contact Human Resources at 407-455-6700.

    Equal Opportunity Employer:
    Jubilant Radiopharma is an Equal Opportunity/Affirmative Action employer. We value diverse perspectives, experiences, and backgrounds, and we are committed to building an inclusive workplace that is representative of the communities we serve.

    We look forward to welcoming a passionate and experienced Senior Manager, Quality Compliance to our team!

     

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