Clinical FSP - Quality Manager

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

• Bachelor's Degree or equivalent qualification.
• Minimum of 5 years' experience in pharmaceutical, bio-pharmaceutical, CRO, or equivalent.
• Minimum of 3 years' experience in a Quality Role.
• Sound working knowledge of medical terminology, SOPs, ICH, GCP, applicable regulatory requirements, and quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA 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 applications.
• Excellent problem solving skills.
• Ability to travel within the region/country.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients/customers.
• Fluent in English.

• Adopt and implement the global Quality Management Plan within the scope of the assignment, including planning and executing Quality Management activities.
• Identify and assess risks through data review and quality control processes.
• Provide support in risk mitigation, planning corrective/preventive actions, and guidance for improvement.
• Support assigned business line management and staff to enhance effectiveness.
• Cooperate closely with relevant business and other stakeholders to maintain focus on quality in project delivery.
• Contribute to the development and implementation of Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor implementation and delivery.
• Provide advice and support on all aspects of Good Clinical Practice (GCP) compliance.
• Manage non-compliance and quality issues, support planning corrective/preventive actions according to SOPs.
• Inform Quality Management, 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 SOPs.
• Provide assistance during audits and regulatory inspections as agreed with business lines.
• Act as primary contact for Quality Assurance on quality matters at the assignment level, attend meetings/teleconferences.
• Prepare periodic reports to business lines on quality related matters, risk assessments, and quality improvement initiatives.
• Perform other reasonable tasks as required by the role upon agreement with the line manager.

IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. IQVIA maintains a zero tolerance policy for candidate fraud. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination in accordance with law.