Clinical FSP Quality Manager

Overview

In this Hybrid Quality Manager role, you will align with global Quality Management and site partners to define and implement a global Quality Plan across assigned scope. You’ll support staff to improve compliance with ICH, GCP, SOPs, KPIs, and regulatory requirements. You’ll oversee quality control, risk management, and CAPA activities, guiding teams and coordinating with QA for audits and inspections. You’ll act as the primary quality contact, report on risk and improvement initiatives, and help drive ongoing quality excellence within the Delivery Unit. This position offers cross-functional collaboration, a focus on practical risk mitigation, and a pathway to shaping quality programs in a G

Responsibilities

• Adopt and implement the global Quality Management Plan within the assignment scope; plan and execute quality activities.
• Identify and assess risks via data review and QC processes; support mitigation and corrective actions.
• Collaborate with business units and stakeholders to maintain quality in project delivery.
• Contribute to the development and delivery of a sponsor-specific Quality Management Plan and Risk Program.
• Advise on GCP compliance and SOP-based quality controls; manage non-conformities.
• Coordinate with QA and business staff on suspected misconduct; support audits/inspections as needed.
• Serve as primary Quality Assurance contact for quality matters; attend meetings and teleconferences.
• Prepare periodic reports on quality, risk assessments, and improvement initiatives.
• Manage staff in line with HR policies; oversee performance and development.
• Perform additional tasks as agreed with the line manager.

Qualifications

• Bachelor's Degree or equivalent qualification; degree field not specified.
• Solid knowledge of medical terminology, SOPs, ICH, GCP, regulatory requirements, and quality management processes.
• Knowledge of national/international regulations and drug development processes.
• Experience with CRO or pharmaceutical industry operations; IQVIA SOPs understanding.
• Strong organizational, interpersonal, communication, judgment, and decision-making skills.
• Strong influencing and negotiation skills.
• Proficiency in Microsoft Office.
• Ability to travel within the region/country.
• Ability to lead and motivate a clinical team.
• Fluent in English.
• Not eligible for UK visa sponsorship.