Responsibilities:
 Oversees the development and implementation of Quality Control strategy and activities for Clinical Operation team. Oversees generation, review and compliance of developed and approved procedures with company-wide quality policies and standards.

 Responsible for the development, maintenance and the communication of high quality standards in the delivery of clinical studies. 

 Secures and improves quality in Clinical Operation by providing training, implementing QC activities and driving quality initiatives.

 Provides compliance and process advice to study teams and identifies opportunities for quality and process improvements.  

 Responsible for the development, implementation and continuing review of  procedural documents, and maintains current knowledge and understanding of regulations and industry practices in relation to clinical trials.

 Supports audits and inspections and is the main contact for auditors from Clinical Operation team.  Advises and monitors Clinical Operation team in the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions.

 Provide co-monitoring visit according to the alignment with study lead.
• Ensures annual study and system QC plan in place, facilitates and monitors the implementation of QC activities by Clinical Operation team.
• Analyses quality status of the function, identifies risk/root cause and comes up with CAPA
• Advises Clinical Operation team on CRO quality management
• Advises/Supports the local study team in the preparation for, conduct of and responses to audits and regulatory inspections.
• Advises local study team in the resolution of the findings in audit and inspection reports. Gives regular feedback/training on audit and inspection findings to Clinical Operation team.
• Shares learnings from audits and inspections with  study team. Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results.
• Works with LMs to ensure the training compliance within function
• Identifies and organises/provides on-going and ad hoc training to Clinical Operation staff according to training needs
 introductory training to new staff, including Procedural Training
 ad hoc local training solutions e.g. as result of serious or recurring quality issues
 (be involved in) other initiatives to identify and share best practices
• Identifies opportunities for quality improvement and optimizing/simplifying relevant processes
• Provides training to Investigational Site staff on GCP, ICH and local regulations, if support needed by local study team
• Creates an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspires teams to achieve goals in the immediate and long term . To be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
Minimum Requirements and Preferred Background
• University degree in related discipline, preferably in life science, or equivalent.
• Fluent knowledge of spoken and written English.
• At least 5 years experience in the multinational pharmaceutical industry, preferably in Clinical Development
• Proceudral Documents generating experience
• Good understanding of the drug development process and related GXP activities
• Good understanding of the skills and knowledge required for the successful delivery of a clinical study, eg. ICH-GCP, study management, site management, monitoring and local regulations
• Good knowledge of local and international regulations and guidelines

• Ability to monitor the internal and external working enviroment and enable changes to drive quality, simplication and efficiency
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Excellent written and verbal communication skills
• Excellent ability to prioritse and handle multiple tasks
• Good  analytical, problem solving, negotiation and conflict resolution skills.
• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global environment
• Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization
• Excellent cultural awareness.
• Integrity and high ethical standards