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Associate Director / Senior Manager, Quality Assurance

Allakos
  • Redwood City, California
    30+ days ago

    Job Description

    Associate Director / Senior Manager, Quality Assurance
     
    Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
     
    Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
     
    Position Summary:
     
    As a member of the Allakos team you will be responsible for quality oversight activities related to Method Validation, Release testing, and Stability for Drug Substance and Drug Product.
     
    Your Role:
    • In collaboration with SME, provide QA review and approval of transfer and or validation protocols/reports to ensure compliance with current regulatory guidance and industry practices
    • Provide Quality oversight of method transfer activities
    • Review data packages for compliance, as applicable
    • Review change controls
    • Lead quality investigation of GMP testing deviations
    • Assist in GMP audits as applicable
    • Collaborate with cross functional team member to resolve quality matters
    • Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
    • Maintain appropriate development phase GMP compliance for release testing, and stability
    • Reviews and assess specifications, validations, reference materials and test results.
    • Review and assess temperature excursions
    • Review and update GMP related SOPs and policies
    Qualifications and Expertise:
    • At least 8 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
    • Bachelor's degree or higher
    • Extensive experience working with Contract Manufacturing Organizations
    • Working knowledge of cGMPs (US and EU)
    • Working experience in GXP environment.
    • Excellent communication skills, both oral and written.
    • Excellent interpersonal skills, collaborative approach essential.
    • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
    • Self-motivated with a strong sense of ownership in areas of responsibility.
    The salary is competitive and commensurate with experience and qualifications.
     
    The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
     
    Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

    Numbers & Facts

    LocationRedwood City, California
    Websitehttps://www.allakos.com/careers/open-positions/

    Skills

    • Antibodiesunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Change Controlunmatched
    • Communication Skillsunmatched
    • Contract Manufacturingunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Documentationunmatched
    • Documentation Standardsunmatched
    • Drug Productsunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • GxPunmatched
    • Inflammatory Diseasesunmatched
    • Interpersonal Skillsunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Materials Testingunmatched
    • Presentation/Verbal Skillsunmatched
    • Quality Assuranceunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Small Companyunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched
    • Testingunmatched
    • Validation Planunmatched
    • Validation Testingunmatched
    • Writing Skillsunmatched

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