Sterility Assurance Lead (Aseptic Quality)

Regulatory Jobs; Greenville (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Healthcare

401K

Tuition Reimbursement

Paid Time Off & Holidays

Annual Bonus

Job summary

Thermo Fisher Scientific is seeking a Sterility Assurance Manager to lead sterility programs across the site. You will own contamination control strategies, oversee EM and media fill programs, and drive improvements in aseptic processing while coordinating with regulators and clients during audits.

The role requires a strong microbiology background, extensive GMP knowledge, and demonstrated leadership in a sterile manufacturing environment.

Qualifications

• Bachelor of Science in Microbiology, Applied Biology, or related field.
• 7 years of microbiology experience required, preferably in sterile pharmaceutical settings.
• 5 years of leadership experience required.
• Experience in pharmaceutical quality function, preferably sterile manufacturing.
• Knowledge of aseptic processing and media fills.
• Familiarity with FDA, EU Annex-1 and related guidance.

Responsibilities

• Define contamination control strategy for assigned areas.
• Oversee the Environmental Monitoring (EM) program and Media Fill program.
• Lead aseptic comportment training and oversight.
• Oversee sterilization processes and risk assessments.
• Lead investigations into sterility issues and adverse EM trends.
• Review and approve major deviations and change proposals with Sterility Assurance impact.
• Represent site with regulators and clients during audits.
• Support new product introductions and capital projects.
• Ensure compliance with updated Annex 1 and harmonize practices across sites.

Skills

Leadership

Investigative skills

Audits

Technical writing

cGMP compliance

Project oversight

Regulatory knowledge

Stakeholder management

Time management

Interpersonal skills

Capital projects

Education

B.S. in Microbiology or related field

Job description

Thermo Fisher Scientific is seeking a Sterility Assurance Manager to lead sterility programs across the site. You will own contamination control strategies, oversee EM and media fill programs, and drive improvements in aseptic processing while coordinating with regulators and clients during audits.

The role requires a strong microbiology background, extensive GMP knowledge, and demonstrated leadership in a sterile manufacturing environment.