General Chemistry Operations Manager

Cardinal Health; United States; On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

HSA

Job summary

Cardinal Health seeks an experienced laboratory leader to drive strategic and operational excellence in the QC Chemistry laboratory in Dublin, Ohio. You will oversee lab operations, equipment lifecycle, CQV, LIMS and CSV, and maintain GMP readiness while supporting inspections.

You will partner with QA, Manufacturing, Engineering, EHS, IT and Scientific Services to advance continuous improvement, data integrity, and risk management across testing programs and EHS initiatives.

Qualifications

• 8–12 years of experience in pharmaceutical/biotech quality labs.
• Bachelor’s degree in a related field preferred; equivalent experience considered.

Responsibilities

• Lead all operational aspects of the Chemistry Center laboratory to ensure compliant, cost‑effective execution.
• Develop strategic plans to support lab growth, capability expansion and business objectives.
• Manage capacity, workflow, staffing, and resource allocation.
• Foster safety, compliance, accountability, and continuous improvement.
• Ensure GMP compliance and audit readiness; oversee deviations, CAPAs, change controls, investigations, and risk assessments.
• Promote data integrity across laboratory systems and processes.

Skills

Leadership

GMP Compliance

Quality Systems

Education

Bachelor’s degree in related field

Tools

LIMS

CSV

CQV

Job description

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.

Responsibilities

Laboratory Operations Leadership 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. Quality and Compliance 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. Extractables & Leachables and USP Testing 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. Laboratory Systems and Validation 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. Facility and EHS Management 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. Operational Excellence and Continuous Improvement 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. Performance Management and Metrics 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. People Leadership 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.

Qualifications

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

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short‑ and long‑term disability coverage
• Work‑Life resources
• Paid parental leave
• Healthy lifestyle programs

Anticipated salary range: $140,300 - $180,360 Bonus eligible: Yes

Key metrics may include

• Testing turnaround time (TAT)
• On‑time testing completion
• Instrument uptime and utilization
• Right‑first‑time performance
• Laboratory productivity
• Training compliance
• Deviation and CAPA closure rates
• Audit and inspection observations
• Safety performance metrics
• Sample throughput
• Customer satisfaction metrics
• Cost management and budget adherence

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.