Quality Manager - Chemistry Lab
Not Disclosed•Full-TimeOn-site
location_on152, Dean Street, Mansfield, Bristol County, Massachusetts, 02048, United States
About the Role
The Quality Manager - Chemistry Laboratory serves as the guardian of laboratory integrity, managing quality programs, policies, and procedures to minimize risk. This role is critical for ensuring uncompromised standards within a GxP environment. The Manager applies advanced knowledge of quality assurance concepts to collaborate cross-functionally, developing solutions for complex quality issues and leading comprehensive quality audits.
In this position, you will lead a team of Quality Assurance and Quality Control Specialists, fostering a high-performing culture through mentorship and performance management. You will oversee the review and approval of QC data, validation of analytical methods, and laboratory metrics to ensure accuracy and precision. Additionally, you will manage the laboratory quality management system, ensuring strict adherence to ISO/IEC 17025, GLP, GMP, and EPA/CLIA standards.
As a liaison with regulators, you will respond to queries and compile necessary information during audits. You will also lead quality audits of distribution centers, reporting issues to Operations teams and providing guidance on process improvements. Your work ensures that standard operating procedures remain aligned with product changes and regulatory developments, setting precedents for resolving significant quality issues such as recalls or customer complaints.
Work location
Work model: On-site
152, Dean Street, Mansfield, Bristol County, Massachusetts, 02048, United States
Mansfield, Massachusetts
Key Responsibilities
- check_circleLead a team of Quality Assurance and Quality Control Specialists through mentorship and performance evaluations
- check_circleProvide guidance to stakeholders on quality policy adherence and assess impacts of operational changes
- check_circleUpdate standard operating procedures in response to product changes and regulatory developments
- check_circleServe as a liaison with regulators and respond to queries during regulatory audits
- check_circleLead cross-functional projects to identify root causes of quality issues and develop risk minimization solutions
- check_circleOversee review and approval of QC data, analytical method validation, and laboratory metrics
- check_circleLead quality audits of distribution centers to ensure operational compliance and guide process improvements
- check_circleManage internal quality policies and programs while ensuring fulfillment of external reporting requirements
- check_circleMaintain the laboratory quality management system to ensure adherence to ISO/IEC 17025, GLP, and GMP standards
- check_circleLead out-of-specification investigations, planned deviations, nonconformances, and corrective actions
Requirements
- verifiedBachelor's degree in chemistry, biochemistry or related scientific field
- verified8+ years of experience in a Quality Assurance role within a GxP laboratory environment
- verifiedPrevious experience as a people leader
Nice to Have
Advanced degrees in chemistry, biochemistry, or related scientific fields.
Benefits & Perks
check_circleMedical, dental, and vision coveragecheck_circlePaid time off plancheck_circleHealth savings account (HSA)check_circle401k savings plancheck_circleAccess to wages before pay day with myFlexPaycheck_circleFlexible spending accounts (FSAs)check_circleShort- and long-term disability coveragecheck_circlePaid parental leave
Similar Job Opportunities
Skills, education and keywords
Skills: Iso/iec 17025, GLP, GMP, Epa, Clia, GXP, Quality Assurance, Quality Control, Standard Operating Procedures, Capa.
Education: Bachelor's degree in chemistry, biochemistry or related scientific field preferred.
Frequently asked questions about Quality Manager - Chemistry Lab at Cardinal Health
What does a Quality Manager - Chemistry Lab at Cardinal Health do?expand_more
In this Quality Manager - Chemistry Lab at Cardinal Health role, you will lead a team of quality assurance and quality control specialists through mentorship and performance evaluations; provide guidance to stakeholders on quality policy adherence and assess impacts of operational changes; update standard operating procedures in response to product changes and regulatory developments; and serve as a liaison with regulators and respond to queries during regulatory audits.
What are the requirements for this Quality Manager - Chemistry Lab role?expand_more
To qualify for the Quality Manager - Chemistry Lab at Cardinal Health position, applicants should have: Bachelor's degree in chemistry, biochemistry or related scientific field; 8+ years of experience in a Quality Assurance role within a GxP laboratory environment; and Previous experience as a people leader.
Where is the Quality Manager - Chemistry Lab role at Cardinal Health located?expand_more
Quality Manager - Chemistry Lab at Cardinal Health is based in 152, Dean Street, Mansfield, Bristol County, Massachusetts, 02048, United States. This is a on-site role.
Is this Quality Manager - Chemistry Lab job remote, hybrid, or on-site?expand_more
Cardinal Health has listed this Quality Manager - Chemistry Lab role as on-site.
How much experience is required for this Quality Manager - Chemistry Lab role?expand_more
Quality Manager - Chemistry Lab at Cardinal Health typically requires 8+ years of relevant experience at the senior level.
What skills do you need for the Quality Manager - Chemistry Lab role at Cardinal Health?expand_more
Key skills for Quality Manager - Chemistry Lab at Cardinal Health include Iso/iec 17025; GLP; GMP; Epa; Clia; GXP; Quality Assurance; and Quality Control.
What education is required for Quality Manager - Chemistry Lab at Cardinal Health?expand_more
Educational requirements for this role: Bachelor's degree in chemistry, biochemistry or related scientific field preferred.
What category does the Quality Manager - Chemistry Lab role belong to?expand_more
Quality Manager - Chemistry Lab at Cardinal Health is part of the scientific & qa job category on Recrutus.