GPS Quality Manager (m/f)

Description

• Implement Quality Management processes to improve the accuracy and timelines of its output, and to meet established standards (e.g. compliance checks)
• Develop and maintain GPS quality standards & metrics for key GPS activities/identify opportunities for improvement for GPS regulated processes
• Review audit reports, propose and monitor action plans (CAPAs), monitor and manage market research and patient support programs deviations
• Lead and coordinate supplier quality assessment for regulated processes in GPS
• Manage multiple stakeholders interacting with global product strategy on regulated processes
• Execute and oversee processes contributing to safety regulatory documents (e.g. periodic benefit risk evaluation report, product risk management plans, development safety update report)
• Prepare and review controlled documents & processes/working guidelines
• Ensure consistency across the organization & act in line with legal, regulatory and company standards and codes of practice

• University degree, preferably in a life sciences/biology/medicine or other healthcare discipline
• Profound experience in pharmacovigilance/compliance related function in pharmaceutical industry at a local, regional or global level
• In-depth knowledge of GVP, healthcare and medical compliance, SOPs and regulatory requirements
• Demonstrated professional experience in a global organization on improving processes in a regulated environment
• Fluency in written and verbal English
• Mastery of office suite tools (Microsoft, Google Suite)
• Knowledge on controlled document environments (e.g. Touchpoint, Condor)
• Experience in Quality Risk Management or Quality Management is of advantage
• Strong analytical and decision making skills in a complex, fast paced and changing environment