Sr Manager Quality, Contamination Control Strategy Lead
Simtra BioPharma Solutions
Bloomington, Indiana, United States
On-site
Contamination control strategy leadership
Aseptic observer program oversight
Regulatory compliance fda ema pic/s
Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market
Job Summary
Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.
The Sr Manager Quality, Contamination Control Strategy Lead is responsible for establishing, maintaining, and continuously improving the contamination control strategy at a sterile injectable manufacturing facility while driving compliance with regulatory requirements.
Employees are eligible for comprehensive benefits including medical and dental coverage, 401(k) with company match, paid time off, adoption reimbursement, education assistance, and onsite amenities such as a workout facility and cafeteria.
Matching Summary
Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.
Skills & Requirements
Must-have
Contamination control strategy leadership
Aseptic observer program oversight
Regulatory compliance FDA EMA PIC/S
Cleanroom behavior and gowning management
Microbiological risk assessment
Sterile injectable manufacturing expertise
Nice-to-have
Cross-functional team collaboration
Mentoring and training staff
Strong technical writing skills
Continuous improvement project leadership
Client and regulatory agency interfacing
Problem-solving in technical environments
Key Requirements
Bachelor's degree in Microbiology or related science
Master's degree preferred in Microbiology or Pharmaceutical Sciences
Minimum 8 years sterile pharmaceutical manufacturing experience
At least 5 years SME contamination control experience
Experience with FDA, EMA regulatory inspections
Knowledge of EU GMP Annex 1 and 21 CFR parts 210/211
Gowning certification for Grade A/B aseptic environments