Quality Manager – Chemistry Lab

Cardinal Health • Mansfield, MA

1d

About The Position

The Quality Manager - Chemistry Laboratory manages quality programs, policies, and procedures in order to minimize risks and drive uncompromised laboratory integrity. Applying advanced knowledge of quality assurance concepts and technical capabilities, the Manager collaborates cross-functionally to develop solutions to complex quality issues and leads quality audits. When creating new standard operating procedures or making revisions to existing practices, the Manager is responsible for ensuring alignment within the organization and monitoring adherence to the policies. The Manager leads a team of Quality Assurance and Quality Control Specialists and manages the operations of the Quality department.

Requirements

• Bachelor’s degree in chemistry, biochemistry or related scientific field preferred
• 8+ years of experience in a Quality Assurance role within a GxP laboratory environment preferred
• Previous experience a people leader

Nice To Haves

• Advanced degree is desired

Responsibilities

• Leads a team of Quality Assurance and Quality Control Specialists, providing mentorship, delegating tasks, and conducting performance evaluations to foster a high-performing culture.
• Oversee the review and approval of QC data, validation of analytical methods, and laboratory metrics to ensure accuracy and precision.
• Review and lead out-of-specification (OOS) investigation, planned deviation, nonconformance, corrective and preventive action (CAPA).
• Lead and maintain the laboratory quality management system, ensuring adherence to ISO/IEC 17025, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), or EPA/CLIA standards.
• Manages internal Quality policies and programs to set guidelines for functions across the organization.
• Ensures fulfillment of external reporting requirements for products and operations.
• Provides guidance to internal stakeholders regarding adherence to internal Quality policies and procedures as well as external requirements.
• Assesses Quality implications and impacts of operational and product changes.
• Leads cross-functional projects to identify significant quality issue root causes, educate stakeholders on quality requirements, and develop solutions to minimize future risks.
• Works with Quality Assurance Specialists in a given area, such as recalls, to create recommended resolutions.
• Updates standard operating procedures in response to product changes and regulatory developments.
• Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.
• Serves as a liaison with regulators and responds to regulatory queries.
• Addresses questions and compiles necessary information during regulatory audits.
• Leads quality audits of distribution centers within the region to ensure operational compliance with standard operating procedures.
• Reports quality issues to Operations teams and provides guidance on improving processes.

Benefits

• Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees