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Quality Manager - Lab based

Location:
Livingston
Company:
IQVIA

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Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.



**PURPOSE**



Providing Quality Assurance guidance to the Laboratory Operational team to ensure compliance and timely CAPA responses. Familiar with Quality tools such as root cause analysis, FMEA, CAPA planning and effectiveness checks. Drive quality culture in the laboratory through training and regular monitoring.



**RESPONSIBILITIES**



Ensure compliance with CAP and ISO 15189 regulations through the performance of inspections in all laboratory departments to assess Quality Control processes and records.



Monitor progress of Quality Issues/CAPAs and ensure timely entries in EDA by CAPA owners.



Monitor Lab departmental compliance with required training plans and SOP acknowledgements.



Work with other Managers to provide basic lab training sessions, and to ensure GDR compliance.



Support implementation of training monitoring system and support rollout to other regions.



**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**



In depth knowledge of clinical testing procedures and applicable laboratory testing regulations



Working knowledge of quality assurance and quality control principles



Strong written and verbal communication skills



Good presentation skills and the ability to impart complex data and process to a wide audience.



Ability to establish and maintain effective working relationships with co-workers, managers, clients and auditors.



Knowledge of occupational safety and health rules and regulations



Effective mentoring and coaching skills



Ability to work independently and manage multiple tasks that require collaboration across different Lab departments and other functional areas.



**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**



BSc. diploma is a minimal requirement with substantial experience in the clinical trial environment including experience with CAPA tracking tools, laboratory quality assurance, or other comparable combination of education, training and experience.



HCPC registration desirable



Strong industry knowledge of applicable regulations preferable



At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.



Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.



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