Quality Assurance/Quality Control Team Leader - Laboratory setting

Job Description We are seeking an experienced and detail-oriented Laboratory Quality Manager to lead our quality operations within a GMP-regulated contract testing environment. This role will be located in our lab in Richardson, TX, but will lead/manage the Quality Team in our Round Rock, TX facility as well. This individual will oversee quality systems, ensure compliance with regulatory requirements, and support laboratory teams in delivering accurate, reliable product quality testing results. The Quality Manager will collaborate cross-functionally to drive continuous improvement, maintain audit readiness, and ensure all laboratory activities align with GMP standards Key Responsibilities: Oversee the development, implementation, and maintenance of laboratory quality systems in compliance with GMP and applicable regulatory guidelines (FDA, ICH, ISO). Manage and review product quality testing activities to ensure accuracy, reliability, and regulatory compliance. Lead investigations of deviations, out-of-specification (OOS) results, and laboratory incidents, ensuring thorough root cause analysis and CAPA implementation. Approve and maintain SOPs, quality policies, and documentation to ensure consistency and compliance. Coordinate internal audits, host external regulatory inspections, and respond to audit findings with effective corrective actions. Ensure proper training of laboratory staff on GMP requirements, documentation practices, and quality procedures. Oversee the review and approval of laboratory data, reports, and records for accuracy and compliance with data integrity principles (ALCOA). Collaborate with operations, validation, and supply chain teams to ensure quality integration across workflows. Monitor key performance indicators (KPIs) and quality metrics to drive continuous improvement initiatives. Stay current with evolving regulatory requirements and industry best practices, recommending updates to procedures and systems as needed. Required Qualifications : Bachelor’s degree in Microbiology, Chemistry, Biology, or related scientific field (advanced degree). Minimum of 5–7 years’ experience in a GMP-regulated laboratory environment, with at least 3 years in a quality management or supervisory role. Strong knowledge of GMP, GLP, and applicable FDA/ICH guidelines. Proven experience in product quality testing, data review, and quality oversight. Demonstrated ability to manage audits, regulatory inspections, and CAPA processes. Excellent leadership, organizational, and communication skills. Proficiency with laboratory information systems (LIMS) and electronic documentation systems. Supreme attention to detail. Ability to be a self-starter and critical thinker while working cooperatively with others in a small-company environment. Desired Qualifications : Bachelor’s Degree with a Chemistry focus. Prior work experience in a laboratory setting. Deep technical knowledge of microbiology theory and practice. Technical knowledge of chemistry testing. Experience in the safe handling of pathogenic microorganisms. Proficiency in Microsoft Office. Ability to travel as needed to HQ for training/events. Interact with and provide detailed information to collaborating personnel. Maintain a safe, fast-paced, and positive laboratory environment. Other duties, as assigned.

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