The world's leading pharmaceutical services organization is powering the next generation of healthcare.  If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed.

More than 19,000 people throughout the world have already chosen to join Quintiles. 

Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
 
We are looking for suitable individuals to fill the position of Senior Clinical Operations Quality Specialist / Clinical Operations Quality Manager role :

Job Responsibilities:
• Conduct on site risk assessment visits with CRAs to investigate risks associated with the conduct of clinical trials and the tasks performed on site in the normal course of business.
• Document the risk assessments by collecting, reporting and analyzing data from the areas of concern pre-identified by the Clinical Operations Quality Manager or designee.
• May be assigned as a liaison to specific sponsors or therapeutic group for risk assessment visits.
• Assist in implementation and delivery of the agreed upon Global Quality Control plan which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.
• Act as a trainer and mentor for Clinical Operations Quality Specialists.
• Conduct routine monitoring activities for an assigned project as required.
• Provide feedback to Clinical Operations Quality Manager or designee on all aspects of compliance, SOP development and customer requirements and work closely with operational teams to review, escalate and manage the quality issues, assist in corrective action plans preparation and implementation. This includes providing assistance during audits and regulatory inspections and partnering with QA in case of suspicions of fraud or misconduct.
• Inform Clinical Operations Quality Manager or designee of significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions, as well as patient safety, regulatory compliance and data integrity.
• Act as a trainer and mentor for Clinical Operations Quality Specialists.
• For Managerial position, you will be also responsible for implementing and delivering the agreed upon Global Quality Control plan for the country which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines. In addition to the Global plan, contribute to the development of and will be responsible for implementation and delivery of specific regional/local initiatives as defined and agreed upon with Regional Quality Management. Provide advice and support to local Clinical Operations, including Project Managers and other key local stakeholders with regard to quality control, risk assessment and management, and corrective action

Requirements:
• Bachelor's degree in a healthcare or other scientific discipline and 5 years of on-site monitoring experience; or equivalent combination of education, training and experience.
• Candidate who has more than 5 years' of relevant experience, including 2 years of lead role will be considered for managerial position.

• Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulation and quality performance initiatives and processes
• Knowledge of CRO or Pharmaceutical industry operations
• Knowledge of Quintiles corporate standards and SOPs
• Good organizational, interpersonal and communication skills
• Good judgement and decision-making skills
• Strong influencing and negotiation skills
• Strong computer skills including Microsoft Office and Clinical Management applications
• Excellent problem solving skills
• Demonstrated ability to work in a matrix environment
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Prior Quintiles clinical monitoring experience is required.