General Chemistry Operations Manager

About This Role

This role provides strategic and operational leadership for the QC Chemistry laboratory, ensuring the highest standards of compliance, quality, safety, and operational excellence. The incumbent oversees all laboratory operations, including facility and equipment maintenance, instrument lifecycle management, computer system validation (CSV), commissioning, qualification and validation (CQV), Laboratory Information Management Systems (LIMS), laboratory Environmental Health and Safety (EHS) programs, and Quality Management System (QMS) processes to maintain continuous GMP readiness and inspection preparedness. The Manager establishes and monitors key performance indicators (KPIs) and operational metrics related to safety, compliance, turnaround times, laboratory utilization, instrument uptime, right-first-time performance, deviations, CAPAs, training compliance, and customer service.

Responsibilities

• Lead all operational aspects of the Chemistry Center laboratory to ensure efficient, compliant, and cost-effective execution of laboratory activities
• Develop and implement strategic plans to support laboratory growth, capability expansion, and business objectives
• Manage laboratory capacity, workflow prioritization, staffing, and resource allocation
• Foster a culture of safety, compliance, accountability, and continuous improvement
• Ensure continuous GMP compliance and maintain a state of audit and inspection readiness
• Oversee implementation and maintenance of QMS processes, including deviations, CAPAs, change controls, investigations, and risk assessments
• Ensure compliance with FDA, USP, ICH, EMA, and other applicable regulatory requirements
• Promote and sustain data integrity principles across laboratory systems and processes
• Provide operational oversight for extractables and leachables (E&L) studies supporting product and packaging qualification
• Ensure effective execution of extraction studies, method development, method validation, and routine E&L testing activities
• Oversee USP compendial testing programs and ensure compliance with current pharmacopeial requirements

About the Company

Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Chemistry performs laboratory testing to characterize the chemical properties of medical device and pharmaceutical products. This job family develops and executes test protocols using specialized instrumentation and analytical techniques to assess chemical properties of finished drug products, medical devices, materials, processing aids, and the chemical constituents which may be released when a device is used in a clinical setting as well as the stability of pharmaceutical products.