QA Manager

Job Title:

Quality Assurance Manager

Job Description

The Quality Assurance Manager oversees the laboratory's Quality Management System to ensure consistent quality, robust policies, and regulatory compliance. This role leads continuous improvement initiatives, verifies adherence to standards, and supports the laboratory in achieving its mission and objectives. The Quality Assurance Manager serves as a key liaison between laboratory operations, regulatory requirements, and clients, while managing QA staff and fostering a strong quality culture.

Responsibilities

+ Lead the laboratory's quality function proactively and foster a culture of continual improvement in quality, processes, and procedures.

+ Coordinate, implement, and maintain the laboratory's Quality Management System in collaboration with the Laboratory Director, Laboratory Manager, Group Leaders, and laboratory staff.

+ Oversee document control and quality records, ensuring that controlled documents and records are accurate, current, and compliant with applicable standards.

+ Manage training documentation to ensure personnel are properly trained, qualified, and documented for their assigned responsibilities.

+ Plan, coordinate, and support internal and external audits, including scheduling, execution, documentation, and follow-up on findings.

+ Administer corrective and preventive actions (CAPA) and continuous improvement activities, ensuring timely resolution and effective preventive measures.

+ Coordinate proficiency testing, including scheduling, reporting results, and following up on any issues or non-conformances identified.

+ Manage supplier qualification and traceability processes, ensuring that suppliers meet quality and regulatory expectations.

+ Serve as archivist for Good Laboratory Practice (GLP) study-specific records, ensuring proper storage, organization, and traceability of critical documentation.

+ Ensure internal audits of the Quality Management System are performed at least annually to maintain compliance with applicable standards and accreditation programs.

+ Identify areas of non-conformance and opportunities for improvement, and drive actions to address findings from audits and reviews.

+ Prepare special reports for regulatory agencies and clients, including summary reports of analytical results, external audit responses, FDA data packages, and ODA data packages.

+ Verify that new method validations and method improvements comply with internal policies and applicable regulatory requirements.

+ Write, review, and maintain Quality Management System standard operating procedures (SOPs) and related documentation in collaboration with the Quality Assurance Unit, Laboratory Manager, Laboratory Director, and other relevant departments.

+ Review controlled laboratory documentation for compliance, accuracy, and quality, ensuring alignment with SOPs, laboratory practices, and regulatory requirements.

+ Perform procedural audits of laboratory methods against applicable SOPs, laboratory procedures, and regulatory requirements to confirm accuracy and adherence.

+ Provide periodic reports to the Laboratory Manager and Laboratory Director on laboratory quality performance, audit observations, findings, non-compliances, and non-conformances.

+ Make recommendations for corrective actions and process improvements to enhance laboratory quality and compliance.

+ Coordinate Annual Quality Review Meetings with laboratory management and compile data and information throughout the year to prepare the annual Management Review of the Quality System report.

+ Coordinate and manage verification and maintenance of scheduled calibration for laboratory support equipment to ensure accurate and reliable operation.

+ Assist sales and marketing teams by responding to quality assurance-related inquiries from existing and potential clients.

+ Coordinate and conduct laboratory meetings to communicate updates on laboratory operations, regulatory changes, quality improvements, and quality issues.

+ Coordinate and deliver quality assurance training for laboratory personnel to maintain and enhance quality awareness and competence.

+ Supervise QA Associate and/or Assistant…