Sterility Assurance Director

Posted 15 May 2024
Contact NameNatasha Cole

Job 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