Principal Specialist, Quality Assurance
Cardinal Health, Mansfield, MA, United States
What Quality Assurance contributes to Cardinal Health
Quality Assurance at Cardinal Health is dedicated to developing and implementing robust quality policies, procedures, and processes to ensure that all products and services consistently meet regulatory standards and specifications. We are committed to establishing and maintaining a compliant and cost‑effective quality system that guarantees the reliability, safety, and effectiveness of our offerings. This involves providing expert oversight of production and manufacturing activities, delivering essential training to operational and quality control personnel, and educating business leaders on critical quality policies and procedures. Our ultimate goal is to ensure that all products and services undergo thorough quality review and are meticulously documented.
Job Summary
The Principal Specialist, Quality Assurance, is a highly experienced individual contributor who applies advanced knowledge of quality assurance concepts and technical capabilities to drive uncompromised laboratory integrity and minimize risks. This role is pivotal in leading the improvement of quality processes and systems. The Principal Specialist collaborates cross‑functionally to develop innovative solutions to complex quality issues and independently leads significant quality audits. When developing new standard operating procedures or revising existing practices, the Principal Specialist is responsible for ensuring organizational alignment and monitoring adherence. This role requires a proactive leader who can step up to provide guidance and direction in the absence of the manager, ensuring continuity and effective decision‑making within the Quality Assurance function.
Responsibilities
Process Improvement Leadership: Proactively identifies opportunities and leads initiatives for the continuous improvement of quality policies, programs, and processes across the organization, ensuring they are compliant, efficient, and effective.
Leadership in Manager's Absence: Act as a key leader and decision‑maker when the manager is unavailable, providing guidance, resolving critical issues, and ensuring the smooth continuation of quality assurance operations.
Expert Guidance & Mentorship: Serve as a subject matter expert, providing advanced guidance and mentorship to less experienced quality assurance and quality control specialists, fostering a culture of excellence and continuous learning.
Policy Development & Implementation: Lead the development, implementation, and continuous enhancement of internal quality policies and programs, ensuring alignment with external reporting requirements for products and operations.
Cross‑functional Collaboration: Lead complex cross‑functional projects to identify root causes of significant quality issues, educate stakeholders on quality requirements, and develop sustainable solutions to minimize future risks.
SOP Management: Drive the update and revision of standard operating procedures in response to product changes, regulatory developments, and resolutions to significant quality issues, setting precedents for best practices.
Regulatory Liaison: Serve as a primary liaison with regulators, responding to regulatory queries, and compiling necessary information during regulatory audits.
Quality Audits: Lead quality audits to ensure compliance with standard operating procedures, reporting findings to operations teams, and providing expert guidance on process improvements.
Laboratory Quality Oversight: Oversee the review and approval of QC data, validation of analytical methods, and laboratory metrics to ensure accuracy and precision. Lead out‑of‑specification investigations, planned deviations, nonconformances, and corrective and preventive actions (CAPA).
Quality Management System (QMS) Leadership: Lead and maintain the laboratory quality management system, ensuring rigorous adherence to ISO/IEC 17025, GLP, GMP, or EPA/CLIA standards.
Qualifications
Bachelor's degree in chemistry, biochemistry, or a related scientific field is required. An advanced degree is a plus.
A minimum of 4–8 years of progressive experience in a quality assurance role within a GxP laboratory environment, demonstrating increasing levels of responsibility and technical expertise.
Proven experience leading projects, initiatives, or significant quality improvement efforts.
Demonstrated ability to act autonomously and make critical decisions in complex situations.
What is Expected of You and Others at This Level
Operate as a highly influential individual contributor, providing expert guidance and technical leadership without direct supervisory responsibilities.
Takes initiative and ownership, stepping up to lead critical functions and decision‑making in the absence of management.
Lead the development and implementation of policies and procedures, driving continuous improvement to achieve strategic goals.
Decisions have a significant impact on work processes, outcomes, and customer satisfaction, often influencing long‑term quality strategy.
Interact and influence peers, customers, suppliers, and senior management, gaining consensus and driving alignment on complex quality issues.
Act as a mentor and coach to less experienced team members, sharing knowledge and best practices.
Champion quality, GMP compliance, and EHS/Radiation Safety practices, actively partnering with plant management to troubleshoot deficiencies and implement corrective measures.
Anticipated Salary Range
$90,600 - $116,460
Bonus Eligible
No
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
Application Window
Application window anticipated to close: 5/1/2026. If you are interested in this opportunity, please submit an application as soon as possible.
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 / Affiantive Action 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 or 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.
#J-18808-Ljbffr
Quality Assurance at Cardinal Health is dedicated to developing and implementing robust quality policies, procedures, and processes to ensure that all products and services consistently meet regulatory standards and specifications. We are committed to establishing and maintaining a compliant and cost‑effective quality system that guarantees the reliability, safety, and effectiveness of our offerings. This involves providing expert oversight of production and manufacturing activities, delivering essential training to operational and quality control personnel, and educating business leaders on critical quality policies and procedures. Our ultimate goal is to ensure that all products and services undergo thorough quality review and are meticulously documented.
Job Summary
The Principal Specialist, Quality Assurance, is a highly experienced individual contributor who applies advanced knowledge of quality assurance concepts and technical capabilities to drive uncompromised laboratory integrity and minimize risks. This role is pivotal in leading the improvement of quality processes and systems. The Principal Specialist collaborates cross‑functionally to develop innovative solutions to complex quality issues and independently leads significant quality audits. When developing new standard operating procedures or revising existing practices, the Principal Specialist is responsible for ensuring organizational alignment and monitoring adherence. This role requires a proactive leader who can step up to provide guidance and direction in the absence of the manager, ensuring continuity and effective decision‑making within the Quality Assurance function.
Responsibilities
Process Improvement Leadership: Proactively identifies opportunities and leads initiatives for the continuous improvement of quality policies, programs, and processes across the organization, ensuring they are compliant, efficient, and effective.
Leadership in Manager's Absence: Act as a key leader and decision‑maker when the manager is unavailable, providing guidance, resolving critical issues, and ensuring the smooth continuation of quality assurance operations.
Expert Guidance & Mentorship: Serve as a subject matter expert, providing advanced guidance and mentorship to less experienced quality assurance and quality control specialists, fostering a culture of excellence and continuous learning.
Policy Development & Implementation: Lead the development, implementation, and continuous enhancement of internal quality policies and programs, ensuring alignment with external reporting requirements for products and operations.
Cross‑functional Collaboration: Lead complex cross‑functional projects to identify root causes of significant quality issues, educate stakeholders on quality requirements, and develop sustainable solutions to minimize future risks.
SOP Management: Drive the update and revision of standard operating procedures in response to product changes, regulatory developments, and resolutions to significant quality issues, setting precedents for best practices.
Regulatory Liaison: Serve as a primary liaison with regulators, responding to regulatory queries, and compiling necessary information during regulatory audits.
Quality Audits: Lead quality audits to ensure compliance with standard operating procedures, reporting findings to operations teams, and providing expert guidance on process improvements.
Laboratory Quality Oversight: Oversee the review and approval of QC data, validation of analytical methods, and laboratory metrics to ensure accuracy and precision. Lead out‑of‑specification investigations, planned deviations, nonconformances, and corrective and preventive actions (CAPA).
Quality Management System (QMS) Leadership: Lead and maintain the laboratory quality management system, ensuring rigorous adherence to ISO/IEC 17025, GLP, GMP, or EPA/CLIA standards.
Qualifications
Bachelor's degree in chemistry, biochemistry, or a related scientific field is required. An advanced degree is a plus.
A minimum of 4–8 years of progressive experience in a quality assurance role within a GxP laboratory environment, demonstrating increasing levels of responsibility and technical expertise.
Proven experience leading projects, initiatives, or significant quality improvement efforts.
Demonstrated ability to act autonomously and make critical decisions in complex situations.
What is Expected of You and Others at This Level
Operate as a highly influential individual contributor, providing expert guidance and technical leadership without direct supervisory responsibilities.
Takes initiative and ownership, stepping up to lead critical functions and decision‑making in the absence of management.
Lead the development and implementation of policies and procedures, driving continuous improvement to achieve strategic goals.
Decisions have a significant impact on work processes, outcomes, and customer satisfaction, often influencing long‑term quality strategy.
Interact and influence peers, customers, suppliers, and senior management, gaining consensus and driving alignment on complex quality issues.
Act as a mentor and coach to less experienced team members, sharing knowledge and best practices.
Champion quality, GMP compliance, and EHS/Radiation Safety practices, actively partnering with plant management to troubleshoot deficiencies and implement corrective measures.
Anticipated Salary Range
$90,600 - $116,460
Bonus Eligible
No
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
Application Window
Application window anticipated to close: 5/1/2026. If you are interested in this opportunity, please submit an application as soon as possible.
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 / Affiantive Action 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 or 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.
#J-18808-Ljbffr