General Chemistry Operations Manager

Cardinal Health•Mansfield, MA

6h•Onsite

About The Position

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. What Chemistry contributes to 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 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.

Requirements

8-12 years of experience
Bachelor’s degree in related field, or equivalent work experience

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.
Maintain laboratory capabilities to support product lifecycle, regulatory submissions, and customer requirements.
Lead governance and compliance of Laboratory Information Management Systems (LIMS).
Oversee Computer System Validation (CSV) activities for laboratory software and computerized systems.
Direct Commissioning, Qualification, and Validation (CQV) activities for laboratory instruments, utilities, and equipment.
Ensure instrument qualification, calibration, preventive maintenance, and lifecycle management programs are executed effectively.
Oversee facility maintenance activities to ensure laboratory infrastructure supports business and compliance requirements.
Partner with EHS teams to maintain a safe working environment and ensure compliance with applicable environmental, health, and safety regulations.
Lead laboratory risk assessments and implementation of corrective actions to mitigate operational risks.
Identify opportunities to optimize laboratory processes, increase efficiency, and reduce operational risks.
Implement Lean, Six Sigma, and continuous improvement methodologies where appropriate.
Support digital transformation initiatives, automation, and modern laboratory technologies.
Drive standardization of laboratory practices and operational procedures.
Establish, monitor, and communicate departmental Key Performance Indicators (KPIs) and operational metrics.
Utilize performance data to identify trends, mitigate risks, and drive informed decision-making.
Develop action plans to improve operational performance and customer satisfaction.
Lead, coach, and develop laboratory personnel to build a high-performing organization.
Establish performance expectations and development plans for team members.
Support succession planning, workforce development, and talent management initiatives.
Promote cross-functional collaboration and employee engagement.