Director of Sterility Assurance

2 weeks ago


Reston, Virginia, United States BioTalent Full time

Unlock Your Potential as a Sterility Assurance Associate Director

BioTalent is seeking a highly skilled and experienced Sterility Assurance Associate Director to join our team in North Carolina. As a key member of our quality assurance team, you will be responsible for leading and overseeing Microbiology, Sterility Assurance & Contamination Control strategies and teams.

This role offers:

  • A unique opportunity to make a significant impact on the development of quality systems and sterility assurance programs.
  • A high degree of autonomy and mobility, working closely with a strong leadership team.
  • The scope to develop and establish state-of-the-art sterility assurance programs for manufacturing facilities, ensuring excellent compliance.
  • A competitive salary, stock purchase program, tuition reimbursement, PTO, 401k match, medical/dental/vision coverage.

Your Key Responsibilities:

  • Develop and implement sterility assurance and microbiology strategies, policies, and procedures for manufacturing facilities.
  • Lead the implementation of quality systems procedures and handle compliance across the department.
  • Oversee and manage microbiology laboratory activities, including environmental monitoring, microbiology testing, and microbial identification.
  • Lead and manage a team of sterility assurance and microbiology professionals.
  • Participate in regulatory inspections and lead quality assessments of internal operations and suppliers to identify risks.
  • Develop a strategy to ensure and improve clean room controls with the facility to minimize risk and cross-contamination.

Desirable Experience and Qualifications:

  • Significant experience in microbiology, sterility assurance, and 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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