Key Responsibilities: Monitor and ensure compliance with quality assurance standards within the QC lab, ensuring that all activities comply with Good Manufacturing Practices (GMP) and applicable regulations. Review and approve lab test results, analytical procedures, and other relevant documentation to ensure all are complete, accurate, and compliant with industry regulations (FDA, EMA, ISO, etc.). Prepare for and support internal and external audits and regulatory inspections, ensuring full adherence to applicable regulatory requirements and company policies. Proactively identify potential risks in testing processes and laboratory operations, and lead investigations and corrective/preventive actions (CAPA) to mitigate issues, ensuring compliance and quality standards are consistently met. Provide mentorship and training to junior QA staff and laboratory personnel, ensuring adherence to current GMP, and SOPs, and fostering a culture of quality within the lab. Oversee and ensure proper validation of laboratory test methods, including biologic, microbiology, and recipient testing in alignment with regulatory requirements and industry best practices. Drive continuous improvement initiatives in laboratory testing processes, equipment, and systems to improve efficiency, accuracy, and quality outcomes. Work closely with other departments, including QA, production, and regulatory teams, to resolve quality-related issues and ensure smooth operations across the lab and wider business functions. Qualifications: Bachelor’s degree in Life Sciences (Microbiology, Biochemistry, Biotechnology, etc.), or a related field. Advanced degree (MS, PhD) preferred. Experience: Minimum 5 years of experience in a Quality Assurance or Quality Control role within a GMP-regulated pharmaceutical laboratory. Solid experience in biological or microbiological testing within the pharmaceutical or biotechnology industry. Comprehensive knowledge of FDA, EMA, and other regulatory requirements. Skills: Strong working knowledge of pharmaceutical QA and QC procedures and regulatory guidelines. Excellent communication skills, both verbal and written, with the ability to interact with various stakeholders. Ability to lead investigations and handle complex quality chall*******n a regulated environment. Proficient in using quality management software, LIMS, and other lab systems for documentation and tracking. Strong leadership and mentoring capabilities