Clinical FSP Quality Manager

In this hybrid role, you will lead and coordinate quality activities to define and implement the global Quality Management Plan for the assigned scope. You will work with global Quality Management, Site Management, and stakeholders to ensure GCP, ICH, and SOP compliance, drive risk management, and oversee corrective/preventive actions. You will act as the primary QA contact, support audits and inspections, and prepare reports on quality matters. This position offers the chance to shape quality governance across the delivery unit and collaborate with cross-functional teams to improve regulatory adherence and patient safety.

• Adopt and implement the global Quality Management Plan within the scope of the assignment and lead Quality Management activities
• Identify risks through data review and quality control processes; support risk mitigation and CAPA planning
• Collaborate with business lines and stakeholders to maintain quality in project delivery
• Contribute to a Delivery Unit/Sponsor-specific Quality Management Plan and Risk Management Program and monitor delivery
• Provide guidance on Good Clinical Practice (GCP) compliance and SOPs; manage non-compliance and CAPA planning
• Inform Quality Management, business line, and Quality Assurance of quality issues per SOPs
• Assist during audits and regulatory inspections as required
• Serve as primary QA contact for quality matters at the assignment level and participate in meetings
• Prepare periodic reports to heads of business lines on quality matters, risk assessments, and improvement initiatives
• Manage staff in line with policies, including performance, development, and HR actions
• Perform other reasonable tasks as agreed with line manager
• Bachelor's Degree or equivalent; education, training, and experience may be substituted
• Solid knowledge of SOPs, ICH, GCP, regulatory requirements, and quality management processes
• Knowledge of National and International Regulations and Drug Development processes
• Experience with CRO or Pharmaceutical industry operations
• Familiarity with IQVIA corporate standards and SOPs
• Strong organizational, interpersonal, and communication skills
• Good judgment, decision-making, and influencing/negotiation skills
• Proficient in 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 colleagues and clients