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.
• Ability to come to the sponsor office in Warsaw three times per week.
• At least 5 years of experience in pharmaceutical industry, preferably in Development Operations/Quality Assurance.
• Good knowledge of international guidelines ICH-GCP and relevant local regulations.
• Good understanding of drug development process and related GXP activities.
• Understanding of skills and knowledge required for successful clinical study delivery (ICH-GCP, study management, site management, monitoring).
• Excellent organizational, verbal and written communication skills; ability to prioritize and handle multiple tasks; attention to detail.
• Good presentation skills, integrity, and high ethical standards.
• Positive approach to managing change for self, team, and business.
• Excellent knowledge of spoken and written English.
• Ability to learn and adapt to work with IT systems; ability to travel nationally and internationally as required.

• Adopt and implement the global Quality Management Plan within the assignment scope, including planning and executing quality management activities, risk identification and assessment, and support in risk mitigation and corrective/preventive actions.
• Cooperate closely with business and other stakeholders to maintain focus on quality in project delivery.
• Contribute to development and implementation of a Delivery Unit/Sponsor-specific Quality Management plan and Risk Management Program, monitoring implementation.
• Provide advice and support regarding Good Clinical Practice (GCP) compliance.
• Manage non-compliance and quality issues, supporting corrective/preventive action planning according to SOPs.
• Inform Quality Management, business line, and Quality Assurance of quality issues as per SOPs.
• Work with Quality Assurance and staff in cases of suspected misconduct according to applicable SOPs.
• Assist during audits and regulatory inspections as agreed.
• Act as primary contact for Quality Assurance on quality matters within assignment scope, attending meetings.
• Prepare periodic reports on quality matters, risk assessments, and quality improvement initiatives.
• Perform other reasonable tasks as required by line manager agreement.

This is a 12 months fixed-term contract with a possibility for extension. Ability to come to the sponsor office in Warsaw three times per week is required. IQVIA maintains a zero tolerance policy for candidate fraud, and false information during recruitment will result in disqualification or termination.