This site uses cookies. To find out more, see our Cookies Policy

Quality Manager - Lab based (R1061125) in Livingston, UK at IQVIA™

Date Posted: 6/5/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Date Posted:
    6/5/2019
  • Job ID:
    R1061125

Job Description

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



Job ID: R1061125