MANAGER QUALITY CONTROL LABORATORY

PRIMARY PURPOSE:

The Quality Control Laboratory Manager will lead and manage the Quality Control Laboratory to ensure all analytical testing, material disposition, and laboratory operations are performed accurately, efficiently, and in full compliance with regulatory and company standards. This role is responsible for maintaining the integrity of testing processes, supporting product quality and safety, driving continuous improvement, and developing laboratory personnel while collaborating cross-functionally to support manufacturing and analytical development activities.

MAJOR DUTIES AND RESPONSIBILITIES:

• Drive a culture of accountability, ownership, and performance excellence throughout the Quality Control Laboratory organization by establishing clear expectations, monitoring performance metrics, reinforcing compliance standards, and ensuring timely execution of commitments and corrective actions.
• Provide leadership and oversight for the daily operations, workflow scheduling, and performance of the Quality Control Laboratory, ensuring efficient execution of all analytical testing activities.
• Supervise, mentor, and develop Quality Control laboratory personnel through training, coaching, performance management, and succession planning initiatives to support organizational growth and technical competency.
• Ensure timely and compliant execution of analytical testing for raw materials, in-process materials, finished products, cleaning validation samples, environmental monitoring samples, and stability samples in accordance with approved specifications and testing procedures.
• Review and disposition raw materials, in-process materials, finished products, and cleaning validation results to support manufacturing operations and product release activities.
• Lead and oversee laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), atypical results, deviations, laboratory events, and corrective and preventive action (CAPA) implementation in accordance with regulatory and internal quality system requirements.
• Ensure laboratory compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), FDA regulations, USP compendial requirements, data integrity standards, and internal Standard Operating Procedures (SOPs).
• Develop, review, approve, and maintain laboratory procedures, test methods, specifications, protocols, reports, and associated quality system documentation.
• Collaborate cross-functionally with Analytical Research & Development (AR&D), Quality Assurance, Manufacturing, and Technical Services to support analytical method development, validation, verification, troubleshooting, method transfer and New Product Launch activities.
• Oversee incoming material inspection and approval processes, including review of Certificates of Analysis (COAs), Incoming Inspection Reports, and verification of compendial compliance requirements.
• Manage laboratory stability programs and retain sample programs, ensuring samples are properly controlled, tested within required timelines, and documented in accordance with regulatory commitments and approved protocols.
• Direct laboratory metrology and equipment lifecycle management activities, ensuring analytical instrumentation is properly qualified, calibrated, maintained, and operating in a validated state.
• Monitor laboratory performance metrics, testing turnaround times (cycle times), investigation trends, and operational efficiencies to support continuous improvement initiatives and overall laboratory effectiveness.
• Lead continuous quality improvement and laboratory transformation initiatives focused on process optimization, workflow standardization, operational efficiency, and implementation of sustainable quality system enhancements.
• Ensure accurate documentation, review, analysis, and interpretation of analytical data in compliance with data integrity requirements and approved laboratory practices.
• Maintain laboratory records, statistical analyses, trend reports, and quality documentation necessary to support regulatory compliance, internal audits, customer audits, and inspection readiness activities.
• Support client interactions, regulatory inspections, internal audits, and customer audits by providing technical expertise, laboratory documentation, and timely responses to observations and requests.

QUALIFICATIONS:

• Strong technical knowledge of analytical testing requirements for raw materials, in-process materials, finished products, cleaning validation samples, and stability samples within a regulated pharmaceutical manufacturing environment.
• Comprehensive understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), FDA regulatory requirements, USP compendial standards, and data integrity expectations applicable to pharmaceutical quality control laboratories.
• Demonstrated expertise in analytical chemistry techniques, laboratory instrumentation, analytical method execution, troubleshooting, and laboratory investigations.
• Working knowledge of analytical method validation, method transfer activities, stability programs, and laboratory equipment qualification and calibration requirements.
• Proven ability to lead laboratory operations in a fast-paced CDMO manufacturing environment while effectively prioritizing multiple projects, timelines, and client-driven deliverables.
• Strong leadership, coaching, and personnel development skills with demonstrated experience mentoring laboratory staff, building technical capabilities, and supporting succession planning initiatives.
• Excellent written and verbal communication skills, including technical writing, investigation documentation, deviation reporting, and cross-functional collaboration with Quality Assurance, Manufacturing, and Analytical Research & Development teams.
• Proficient in laboratory systems, Microsoft Office applications, data analysis, and electronic quality management systems (eQMS/LIMS preferred).

EDUCATION AND/OR TRAINING:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or other relevant life science discipline required.
• Minimum of 8 (eight) years of analytical laboratory experience within an FDA-regulated Pharmaceutical, OTC, cosmetic, medical device, or combination-product manufacturing environment.
• Minimum of five (5) years of laboratory leadership supervisory experience preferred.
• Experience within a contract development and manufacturing organization (CDMO) environment strongly preferred.