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 in Life Sciences or related field
- 5 - 7 years of prior relevant experience in Clinical Research. CRA background preferred
- Sound working knowledge of medical terminology, standard operating procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
- Knowledge of 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 establish and maintain effective working relationships with co-workers, managers and clients/customers.
