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    Sterility Assurance Director - North Carolina, United States - BioTalent

    BioTalent
    BioTalent North Carolina, United States

    Found in: Appcast US C2 - 5 days ago

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    Description

    Senior Manager, Microbiology & Sterility Assurance – North Carolina – Competitive Package

    I am representing an established, global health care provider who is on the search for a Sterility Assurance Director. You will be responsible for leading and overseeing a Microbiology team across key laboratory activities and projects.

    This role will offer you:

    • A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives.
    • A lot of mobility and autonomy in the role, while working with a strong leadership team.
    • The scope to develop and establish the sterility assurance program for state-of-the-art manufacturing facilities ensuring excellent compliance
    • Competitive salary, stock purchase program, Tuition reimbursement, PTO, 401k match, Medical/Dental/Vision coverage

    You will be responsible for:

    • Develop and implement sterility assurance and microbiology strategies, policies, and procedures for the company's manufacturing facilities.
    • Leading the implantation of quality systems procedures and handling compliance across the department
    • Overseeing and managing microbiology laboratory activities - environmental monitoring, microbiology testing, microbial identification
    • Leading and managing a team of sterility assurance and microbiology professionals
    • Participate in regulatory inspections and lead the quality assessment of internal operations & suppliers to assess any risks
    • Responsible for the strategy to ensure and improve clean room controls with the facility to minimize risk and cross-contamination

    Desirable experience and qualifications:

    • Significant experience with microbiology, sterility assurance, aseptic processing within pharmaceutical/biotech manufacturing
    • BS degree in Science, concentration in Biology or Microbiology, preferably
    • Proven experience managing and leading teams
    • Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing
    • Experience with regulatory inspections and audits
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