GPS Quality Manager (m/f)

REFERENZNUMMER:

356278/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Drug safety manager