Senior Manager Quality, Contamination Control Strategy Lead

Responsibilities

• Own the aseptic observer program, including oversight of aseptic practices, cleanroom behavior, and gowning
• Lead the development and implementation of the Contamination Control Strategy (CCS) according to EU GMP Annex 1
• Serve as the Subject Matter Expert (SME) during regulatory inspections and audits regarding aseptic processing
• Collaborate with manufacturing, microbiology, and QC to ensure appropriate cleanroom qualification and environmental monitoring
• Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs
• Review and approve GMP documents related to aseptic processing, including SOPs, protocols, and batch records
• Mentor and train aseptic operators and QA personnel in contamination control

Requirements

• Bachelor's degree in Microbiology, Biology, Pharmacy, or related science
• Minimum 8 years of experience in sterile pharmaceutical manufacturing or QC microbiology/QA roles
• At least 5 years of experience in an SME capacity related to contamination control
• Demonstrated leadership in aseptic processing environments (e.g., isolators, RABS)
• Proven track record of successful regulatory inspection participation (FDA, EMA)
• Strong knowledge of EU GMP Annex 1, 21 CFR parts 210/211, and USP standards
• Strong technical writing and communication skills
• Ability to work in Grade A/B aseptic environments requiring gowning

Preferred Qualifications

• Master's degree or higher in Microbiology or Pharmaceutical Sciences

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.