Quality Management Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

• Maintain and approve assigned quality issues and CAPAs in the electronic Quality Management System (eQMS).
• Support the internal customer for the assigned records in the quality issue and root cause/CAPA process.
• Contribute to improvements for the eQMS.
• Contribute to the process monitoring and continues improvement of the Quality Issue and CAPA process. It includes maintaining metrics and KPIs and performing overseeing the data quality in the eQMS.
• Drives quality into the business through proactive quality support, training, mentoring and/or coaching, and consultation (quality by design).
• Advises internal customers, as well as functional lines, and stakeholders on how to address issues while maintaining compliance with worldwide regulations, guidelines, 
• Proactively identifies risk areas – brings ideas and strategies to the forefront and has a firm grasp of the business needs.
• Contribute and participate in health authority inspections.

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• In depth Quality Assurance (QA) experience or relevant experience in international pharmaceutical and/or biotech industry, quality management, clinical development, or regular compliance with extensive knowledge in clinical development QA.
• 3y in a similar position
• Experience in managing deviations, quality issues or observations.
• Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedure e.g. strong quality orientation and understanding of metrics; Lean Six Sigma training or alternative trainings
• In depth knowledge of applicable worldwide GCP regulations and ICH guidelines, and applicable worldwide computerized system validation principles (e.g., GAMP5).
• Basic knowledge of other GxP disciplines like GVP, GLPs, GRPs or GMPs.
• Solid working knowledge of principles and concepts of risk-based QA.
• Critical mindset
• Broad understanding of the drug development process and regulatory environment.
• Knowledge in computerized system development.
• Fluent in written and spoken English.
• High learning agility and self-motivated worker.
• Excellent communication, problem-solving, and organization skills, attentive, careful, and meticulous, strong team player with intercultural skills