Functional Manager. QC Laboratory Operations

JOB SUMMARY
Functional Manager, QC Lab Operations is responsible for leading and managing all Quality Control Laboratory activities to ensure compliance with applicable regulatory standards, including ISO 13485, 21 CFR Part 820, 210, and 211. This position oversees laboratory operations, staff performance, analytical testing, and data integrity, while driving continuous improvements in quality and compliance. The role is critical in supporting the release of medical devices and pharmaceutical products that meet regulatory and customer expectations.
ESSENTIAL DUTIES
• Oversee daily operations of the QC laboratory, including raw material, in-process, finished product, and stability testing for both medical devices and pharmaceuticals.
• Ensure strict compliance with ISO 13485, 21 CFR Part 820 (QSR), and cGMP regulations under 21 CFR Parts 210 and 211.
• Manage, mentor, and train laboratory personnel, ensuring competency in testing methodologies, data integrity, and good documentation practices (GDP).
• Lead analytical method development, verification, validation, and transfer activities according to ICH, FDA and other regulatory guidelines.
• Review and approve test results, analytical reports, deviations, NCs, out-of-specification (OOS) results, and ensure appropriate investigations and CAPAs are executed.
• Oversee maintenance and qualification of laboratory instruments; ensure instruments are operating within validated parameters.
• Author, review, and maintain SOPs, protocols, specifications, and quality records in alignment with company quality management systems.
• Prepare for and support internal audits, third-party inspections, and regulatory audits (e.g., FDA, ISO).
• Collaborate with cross-functional teams including QA, Regulatory, R&D, Manufacturing, and Supply Chain to support compliance and timely product release.
• Monitor laboratory KPIs and drive continuous improvement projects using tools such as Root Cause Analysis (RCA), CAPA, and Risk Management (ISO 14971).
• Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Adequately participates in and supports the problem-solving needs of operating groups for all areas of the company and the development of new products.
• Communicates performance expectations and business and corporate policies to section staff and others. Ensures accurate and complete associate records are maintained within the section.
• Develops and maintains systems for tracking projects and continuous improvement activities.
• Representing QA for final approval Validation / Study / Technical / Activities documents, etc. at Lab section