Essential Functions

Adopt and implement the global Quality Management Plan within the scope of the assignment; this will include:

Planning and executing the Quality Management activities;

Risk identification and assessment through data review and quality control processes;

Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement;

Supporting the assigned business line management and staff to enhance effectiveness.

Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.

Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.

Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.

Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.;

Inform 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 teams to the extent agreed, as required by the applicable SOPs.

Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.

Upon agreement the line manager: Perform any other reasonable tasks as required by the role.

Qualifications

Bachelor's Degree

At least 3 years relevant experience in Quality Management (not in the manufacturing industry)

Sound working knowledge of medical terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.

Knowledge of National and International Regulations and Drug Development processes.

Knowledge Pharmaceutical industry operations.

Good organizational, interpersonal and communication skills. Good judgement and decision-making skills.

Strong influencing and negotiation skills.

Strong computer skills including Microsoft Office applications.

Excellent problem solving skills.

Ability to travel within the region/country.

Ability to lead and motivate a team.

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