Senior QA– Facility & Development (Peptides & Biologics)
Job Description :
Build, lead, and own the Quality Assurance function while supporting facility design,
development activities, regulatory readiness, and scale-up.
Responsibilities :
• Design and implement GMP-compliant QA systems from scratch
• Develop SOPs, templates, quality manual, and validation strategy
• Provide QA oversight for facility layout, HVAC, utilities, and cleanrooms
• Review and approve DQ, IQ, OQ, PQ, URS, FAT, and SAT documents
• Oversee development, analytical, scale-up, and tech transfer QA activities
• Own deviations, change control, CAPA, OOS/OOT, and risk management
• Ensure data integrity and ALCOA+ compliance
• Lead client, regulatory, and investor audits
• Act as single point of contact for QA during inspections
• Mentor junior QA and train cross-functional teams