Development Quality Manager, CPO

Job Description Is responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV), including Patient Oriented Programs. Ensure in direct collaboration and partnership with the CPO Medical Department (including GenMed, Oncology, DS&E, DRA and MA) the implementation of the Quality Manual and Quality Management System in the CPO to achieve a high level of quality and compliance.

• Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Quality Manual and the CPO Quality Plan.
• In cooperation with local DRA and DS&E, keep abreast of regulatory requirements, and update local management and Pharma Development MA/CPO QA on the possible rami-fications of regulatory changes and impact to Clinical Development, MA and PV processes.
• Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appro-priately in order to mitigate risk.
• Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities, including POP vendors. Ensure the ESP selection process properly followed at the CPO.
• Partner with Pharma Development QA & PvP in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
• In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
• Participate in PH Dev QA investigation activities, as appropriate.
• Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity (e.g. local Health Authority [HA] inspections).
• Ensure CPO readiness for all GxP (non-GMP/GDP) regulatory inspections.
• Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/ closed.
• Ensure conduct of adequate training at the CPO for all GCP and GPvP activities by defining, planning and supporting training activities.
• Ensure that the clinical and PV computerized systems are adequately identified during the High Level Risk Assessment for GxP relevance to enable their validation where required.

Key Performance Indicators

• Local GCP/PV Quality System in place and continuously updated, as required
• GCP/PV risks proactively identified and effectively mitigated
• The number and severity of GCP/PV issues identified during internal and external audits
• No regulatory problem / action due to inefficient local Change Control procedure
• Training conducted according to program

Minimum requirements Education (minimum/desirable): Degree in Life Sciences or related fields

Languages: English fluent in speaking and writing.

Experience: Min. 5 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area