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    Quality Associate (Fixed-Term Contract)

    Sanofi
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 8, 2024
    Job Description
    Job Type: Full Time 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

    About the Job

    As a Vaccine Quality Assurance Specialist at Sanofi, you will be responsible for ensuring that our vaccine products and services are fully compliant with corporate directives, GxP (Good Manufacturing Practice), and local regulatory requirements. This role will involve supporting various quality activities, managing technical complaints, and ensuring that products are distributed, manufactured, and imported according to the highest quality standards.

    You will work closely with teams to manage technical aspects related to product release, cold chain management, and regulatory compliance, and ensure the maintenance of all GxP records. In addition, you will support both internal and external stakeholders to ensure adherence to GSP/GMP in the warehouse and oversee the qualification of third-party vendors.

    Key Responsibilities

    1. Ensuring Compliance of Vaccine Products and Services

    • Support national lot release application for vaccine products.
    • Prepare summary protocol for imported products to submit to the Korean Health Authority.
    • Prepare batch release dossier and manage the release of vaccine batches in accordance with local regulations.
    • Operate SAP Quality module for managing vaccine product data.
    • Review package materials to ensure compliance with regulatory standards.
    • Manage affiliate SOPs related to vaccine products.
    • Support change control, risk management, and product recalls.
    • Perform and support self-inspections, regulatory inspections, and CAPAs (Corrective and Preventive Actions).
    • Support the Annual Quality Review and Product Review processes.

    2. Managing Product Complaints and Cold Chain Events

    • Support PTC (Product Technical Complaints) related to vaccine products.
    • Manage cold-chain breaks and ensure the appropriate corrective actions are taken.

    3. Supporting Distribution Center Compliance

    • Assist in ensuring that GSP/GMP standards are implemented at the distribution warehouse.
    • Support the manager to make usage decisions and resolve issues with defective products.
    • Manage KGSP documents and ensure the availability of required regulatory dossiers.

    4. Ensuring Vaccine Products Are Manufactured, Imported, and Distributed Correctly

    • Support the assessment of sub-contractors' KPIs and ensure compliance with quality standards.
    • Manage, archive, and handle change control of quality documents from the manufacturing site.
    • Document archiving for imported vaccine products and ensure compliance with regulatory requirements.

    5. GxP Electronic Records Management

    • Manage and archive GxP records in the GxP archiving tool, ensuring accurate documentation and traceability.

    6. Managing Third-Party Vendors in Compliance with Sanofi Processes

    • Ensure the qualification of third-party vendors and conduct routine management in line with Good Operating Practices (GOP).
    • Perform Quality Risk Assessments (QRA), including market research QRAs, and manage the audit program for third-party suppliers.
    • Maintain an up-to-date QTP Data Base and ensure quality agreements are properly signed and maintained.

    About You

    • Education: A relevant degree in a science or pharmaceutical field. Experience may be considered in place of formal education.
    • Experience: Minimum of 3-5 years in a Quality Assurance or Compliance role within the pharmaceutical or vaccine industry.
    • Knowledge: Strong knowledge of GxP, GMP, and cold chain management as well as SAP and quality document management.
    • Skills:
      • Strong attention to detail and organizational skills.
      • Ability to work in a fast-paced environment and collaborate with multiple departments.
      • Strong communication and problem-solving skills.

    Why Join Us?

    At Sanofi, we believe in driving progress and exploring the extraordinary. Join us to be part of a team that thrives on overcoming challenges, adopting innovative ideas, and continuously advancing in the healthcare industry.

    • Diversity and Inclusion: We believe in the equality of opportunities for everyone, regardless of origin, race, religion, gender, sexual orientation, age, disability, or other protected characteristics.
    • Career Growth: Explore a wide range of opportunities for personal and professional growth as part of a global leader in healthcare.

    Equal Opportunity Employer

    Sanofi is proud to be an Equal Opportunity Employer. We are committed to diversity and do not discriminate based on any protected characteristic. Learn more about our initiatives in diversity, equity, and inclusion at Sanofi Careers.

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