General Chemistry Operations Manager

The incumbent is responsible for providing strategic and operational leadership for the QC Chemistry laboratory, ensuring the highest standards of compliance, quality, safety, and operational excellence. This role 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 incumbent leads laboratory activities supporting routine and non-routine testing, extractables and leachables (E&L) studies, analytical extractions, USP compendial testing, method lifecycle management, and laboratory investigations. The role is accountable for ensuring regulatory compliance, data integrity, operational reliability, and effective execution of testing programs while driving continuous improvement initiatives across laboratory operations.

Additionally, 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. Working closely with Quality Assurance, Manufacturing, Engineering, Validation, EHS, IT, and Scientific Services teams, this position drives a culture of operational excellence, risk management, innovation, and continuous improvement while ensuring the laboratory consistently delivers high-quality, compliant, and business-critical analytical support.

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 our 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.

• 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.
• Maintain…