Quality Manager or specialist
Adopt and implement the Global Quality Management Plan within the scope of the assignment; this will include:
o planning and executing the Quality Management activities;
o risk identification and assessment through data review and quality control processes either remote or on site;
o providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
o supporting the assigned business line management and staff to enhance effectiveness of Site Visits conducted by them.
Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
Provide advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers, Resource Managers and other key stakeholders on all aspects of GCP compliance.
Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.
Work closely with Quality Assurance and assigned business staff in case of suspected misconduct; as required by the applicable SOPs.
May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of QM and as required by the applicable SOPs.
Act as the primary contact for Quality Assurance on clinical quality matters – on the level of the assignment -, attend meetings/teleconferences.
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