Quality Assurance Specialist - GCP​/GLP

Medicilon USA is establishing a Bioanalysis Center of Excellence in Lexington, Massachusetts, supporting GLP preclinical and GCP/GCLP clinical bioanalysis across LC-MS/MS, immunoassays, PCR/qPCR/ddPCR, flow cytometry, and related technologies.

We are seeking an experienced Quality Assurance Specialist to help establish and maintain an independent quality assurance function for our growing bioanalytical operations. This individual will play a key role in developing quality systems, ensuring regulatory compliance, maintaining data integrity, and supporting audit and inspection readiness.

The ideal candidate has hands‑on QA experience in a regulated laboratory, pharmaceutical, biotechnology, or CRO environment. We are looking for someone who is detail‑oriented, proactive, and comfortable building quality processes in a growing organization while collaborating closely with scientific and operational teams.

• Establish, implement, and maintain a Quality Management System (QMS) supporting GLP preclinical and GCP/GCLP clinical bioanalytical operations.
• Develop and maintain standard operating procedures (SOPs), document control, training records, deviations, corrective and preventive actions (CAPA), and change control processes.
• Support compliance with applicable regulatory requirements and industry standards, including ICH M10, ICH E6(R3), 21 CFR Part 11, 21 CFR Part 58, and ALCOA+ data integrity principles.
• Identify compliance risks and recommend practical improvements to strengthen quality systems and laboratory processes.

• Conduct independent, risk‑based audits and inspections of studies, laboratory operations, facilities, equipment, computerized systems, and study documentation.
• Provide QA oversight for bioanalytical method validation, method transfer, sample analysis, data integrity, and study records.
• Review deviations, investigations, CAPA effectiveness, and quality‑related documentation.
• Support qualification and oversight of vendors, subcontractors, and external service providers.

• Support computerized system validation, equipment qualification, calibration, and environmental monitoring programs.
• Ensure appropriate documentation, traceability, and integrity of laboratory data and electronic records.
• Work with laboratory teams to identify quality gaps, resolve compliance issues, and implement process improvements.

• Coordinate and support sponsor audits, customer quality assessments, and regulatory inspections, including FDA Bioresearch Monitoring (BIMO) inspections.
• Maintain inspection‑ready documentation and assist with audit responses, corrective actions, and follow‑up activities.
• Monitor quality metrics and provide regular updates on compliance risks, audit findings, and quality improvement initiatives.

• Partner with scientific leadership, laboratory personnel, and management to promote a strong culture of quality and compliance.
• Provide quality‑related training and guidance to laboratory and operational teams.
• Maintain appropriate independence from laboratory operations, with direct access to senior management for significant quality and compliance concerns.

• Bachelor's degree in life sciences, chemistry, biochemistry, pharmaceutical sciences, or a related field.
• Minimum 2–3 years of quality assurance experience in a regulated laboratory, pharmaceutical, biotechnology, CRO, or bioanalytical environment.
• Experience supporting GLP, GCP/GCLP, and/or regulated bioanalytical operations.
• Working knowledge of applicable regulatory requirements, including ICH M10, ICH E6(R3), 21 CFR Part 11, 21 CFR Part 58, and…