Senior Quality Specialist

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.