QC Laboratory Manager

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

Education and Experience

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Microbiology, or related scientific discipline.

• Minimum 10 years of progressive experience in a QC laboratory within a regulated pharmaceutical and/or medical device environment.

• At least 5 years of supervisory or management experience in a regulated QC lab.

• Strong working knowledge of ISO 13485, 21 CFR Part 820, 210, and 211, as well as ICH Q-series guidelines.

• Hands-on experience with analytical instruments such as HPLC, GC, FTIR, UV-Vis, or microbiological testing assays.

• Proficient in handling deviations, OOS/OOT investigations, and CAPA processes.

• Familiarity with laboratory information management systems (LIMS) and electronic data management (e.g., CFR 21 Part 11 compliance).

• Excellent leadership, communication, documentation, and organizational skills.

Skills

• Experience in both sterile and non-sterile product testing environments.

• Working knowledge of risk management per ISO 14971.

• Familiarity with statistical analysis and quality tools (e.g., Minitab, Six Sigma).

• Experience supporting FDA, EU MDR, or other global regulatory inspections.

• Demonstrated and effective leadership and managerial skills.

• Demonstrated knowledge in applicable regulations affecting areas of responsibility.

• Comprehensive knowledge of the principal chemical, biological, physical, biochemical, and/or environmental techniques as applicable to work assignments.

• Comprehensive knowledge of FDA and international regulations and requirements relevant to work assignments, GMP, IDE, PMA, 510(K), OSHA, EPA, DOT, and ISO.

• Ability to select, develop, and evaluate staff.

• Ability to succeed in a team oriented atmosphere and lead team activities.

• Knowledge and use of relevant PC software applications and skills to use them effectively.

• Demonstrated ability to communicate effectively both verbally and in writing.