Quality Assurance Engineering Lead
Core
Provide quality assurance oversight and governance for global engineering programs in biologics, API, aseptic manufacturing, and medical devices to ensure GMP compliance and contamination control from concept through execution.
Role type
Senior IC Quality Assurance Engineering Lead
Builds
Compliant facility, utility, and equipment designs for global engineering programs
Domain
Pharmaceutical manufacturing (biologics, API, aseptic, terminal sterilization) and GMP regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP principles and contamination control strategy, risk-based qualification (ISPE Baseline Guide Vol 5), quality risk management (ICH Q9), aseptic manufacturing knowledge, terminal sterilization knowledge, API and biologics facility requirements, FDA/EMA regulatory knowledge, system risk assessment (SRA), qualification document review, critical design element determination, test plan assessment
Preferred skills
Experience in engineering, operations, or technical support within pharma, ability to manage multiple priorities in fast-paced environments
Technologies
ISPE Baseline Guide Volume 5, ICH Q9
Responsibilities
Provide quality assurance governance and oversight for global engineering programs; Lead contamination control risk assessments and develop initial contamination control strategies; Make key decisions regarding GMP and quality requirements for facility, utility, and equipment design; Partner with project leads to update regulatory compliance risks in project risk registers; Participate in system risk assessments and review qualification documents; Determine critical design elements impacting product quality and assess proposed test plans.
Seniority
Senior, hands-on IC