Impact Quality Lead - GVP

Our client, a global biopharmaceutical organization, is seeking an Impact Quality Lead to implement and maintain a proactive approach to pharmacovigilance compliance. This role focuses on ensuring that all pharmacovigilance activities adhere to international regulatory requirements while providing strategic quality leadership across post-marketing programs.

• Provide global quality oversight for the pharmacovigilance system and the quality management system.
• Deliver expert guidance on GVP and GCP regulatory expectations, including FDA, EMA, and ICH guidelines.
• Review and ensure compliance for pharmacovigilance outputs such as ICSRs, DSURs, RMPs, and REMS.
• Manage vendor and partner oversight to ensure consistent and compliant delivery of delegated GCP and GVP activities.
• Lead deviation management processes, including root cause analysis and the tracking of CAPA effectiveness.
• Host and support regulatory inspections and audits by developing and implementing remediation plans.
• Collaborate with cross-functional teams to drive quality process improvement initiatives and ensure inspection readiness.

• You have a Bachelor’s degree in Life Sciences, Science, or Engineering.
• You bring 8+ years of experience in GVP, GCP, and pharmacovigilance within the pharmaceutical or biotech industry.
• You possess extensive experience in quality assurance, including CAPA, deviation management, and audit activities.
• You have a demonstrated history of supporting global regulatory inspections and managing GVP quality systems.
• You bring strong analytical, problem-solving, and communication skills with a focus on ethical standards.
• You are fluent in English.

Nice to Haves

• Experience with Veeva Systems or the Argus global safety database.
• Possession of a Master’s degree in a relevant scientific field.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.