Principal Specialist, Quality Assurance

Cardinal Health•Mansfield, MA

18h•Onsite

About The Position

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/ 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. 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.

Requirements

Bachelor’s degree in chemistry, Biochemistry, or a related scientific field is required.
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.
Operates 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.
Leads 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.
Interacts and influences peers, customers, suppliers, and senior management, gaining consensus and driving alignment on complex quality issues.
Acts as a mentor and coach to less experienced team members, sharing knowledge and best practices.
Champions Quality, GMP compliance, and EHS/Radiation Safety practices, actively partnering with plant management to troubleshoot deficiencies and implement corrective measures.

Nice To Haves

An advanced degree is a plus.

Responsibilities

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.
Acts 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.
Serves 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.
Leads the development, implementation, and continuous enhancement of internal Quality policies and programs, ensuring alignment with external reporting requirements for products and operations.
Leads complex cross-functional projects to identify root causes of significant quality issues, educates stakeholders on quality requirements, and develops sustainable solutions to minimize future risks.
Drives 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.
Serves as a primary liaison with regulators, responding to regulatory queries, and compiling necessary information during regulatory audits.
Leads quality audits to ensure compliance with standard operating procedures, reporting findings to Operations teams, and providing expert guidance on process improvements.
Oversees the review and approval of QC data, validation of analytical methods, and laboratory metrics to ensure accuracy and precision. Leads out-of-specification (OOS) investigations, planned deviations, nonconformances, and corrective and preventive actions (CAPA).
Leads and maintains the laboratory quality management system, ensuring rigorous adherence to ISO/IEC 17025, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), or EPA/CLIA standards.