Quality Assurance Manager (QAM)
Date : 28. Mar. 2016
The Quality Assurance Manager (QAM) aims to ensure that service of CERMEL provides is fit for purpose,
is consistent and meets both external and internal requirements. This includes ensuring legal compliance, adherence to local regulations and CERMEL regulations,
and meeting customer expectations.
Planning and coordination
The QAM will coordinate the activities required to meet quality standards set forth in CERMEL quality policy and CERMEL quality manual.
Specifically, the QAM will ensure that planning, coordination, control,
and continuous improvement of processes and methods are established to control the quality of studies conducted at CERMEL.
This involves working closely with the CERMEL laboratory departments, Clinical Operations, Information Technology,
and other supporting areas, to help ensure active participation in continuous quality improvement activities.
The Quality Assurance Manager also monitors and advises on the performance of the quality management system,
produces data and reports on performance, measuring against set standards.
Communication and training
Quality Managers liaise with managers and staff throughout the organisation to ensure that the quality system is functioning properly.
Where appropriate, the quality manager advises on changes and their implementation and provides training,
tools and techniques to enable others to achieve quality.
Typical work activities
QAM will employ a variety of measures and management systems, including international standards (ISO 15189) and guidelines (GxP/ICH, Industry Guidelines).
The work of the QAM will include the following activities:
- • Devising and establishing CERMEL quality procedures,
standards and specifications in conjunction with operating staff such that processes meet national and international standards;
- • Developing and maintaining GCP/ICH compliant processes which control the quality of work and clinical trials conducted at CERMEL
- • Leading or assisting with activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions),
Management Reviews, and laboratory checks to ensure that studies are conducted in accordance with sponsor protocols,
GCP, industry guidelines, agency regulations.
- • Leading or assisting with the identification of non-conformances with requirements,
providing suitable recommendations and facilitating ongoing quality improvements while maintaining compliance with applicable study protocols,
Quality System Regulations and ISO standards where applicable
- • Reviewing customer requirements and ensuring that they are met;
- • Working with purchasing staff to establish quality requirements from external suppliers;
- • Setting up and maintaining controls and documentation procedures;
- • Monitoring performance by gathering relevant data and producing statistical reports;
- • Acting as a catalyst for change and improvement in performance/quality;
- • Performing other related duties as assigned
- • Demonstrates strong analytical, problem solving skills.
- • Strong written and verbal communication skills.
- • Detail oriented, good organizational traits.
- • Self-motivated, with strong leadership abilities.
- • Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the
- • Team and show a strong track record of meeting deadlines.
- • Good computer skills; inclination to adopt technology to maximize efficiency.
Education and Experience
- • Bachelors Degree or equivalent experience in associated discipline
- • In-depth knowledge of International regulatory standards, and GxP Guidelines for the conduct of clinical trials
- • Experience and knowledge of ISO Standards.
- • Former professional experience working in a Quality Control / Assurance area.