Senior Manager PV Quality

Job title : Senior Manager PV Quality
Location : Munich
Job type : Permanent
Salary : €80000 - €85000 per annum
Contact name : Jonathan Smith
Contact number : +44 (0) 207 255 6633
Contact email : jonathan.smith@seclifesciences.com
Senior Pharmacovigilance Quality Manager
Overview -
The Pharmacovigilance QA Manager will participate in the implementation of the quality strategy that is aligned with the current business strategy. As the Senior Pharmacovigilance QA Manager, you will provide strategic and proactive QA Leadership. This role will advise the current teams in quality and compliance decision making to drive sustainable quality and compliance excellence.
Responsibilities -
* * Support the Head of PV QA, Europe / Global PV Quality with Quality Reviews of relevant product profiles.
* * Facilitate the implementation of the quality plan in close connection with the current PV business strategy.
* Interact with senior PV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process
* Interact with other GxP QA functions to discuss PV problems and issues that have an influence on the respective Pharmacovigilance operations and safety actions in order to effectively communicate with PV.
* Collaborate with the PV and Global PV Quality on quality review of PV System and documents
* Assist in ensuring that relevant PV processes and quality standards adhere to global HA requirements.
* Maintain the respective PV team's readiness for submissions and inspections, as well as any related submissions.
Quality Oversight -
Ensure adequate and timely escalation of incidents/issues within PV and QA. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course
In collaboration with GxP Quality Systems and Compliance provide Quality oversight for deviations/incidents & investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked. Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)
Ensure that proper Quality oversight is implemented for 3rd parties/vendors/outsourced activities
Experience Qualifications:
* Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
* Master's Degree advanced degree in Life Sciences, Pharmacy or Medicines preferred
* 6 years of involvement in the area of Pharmacovigilance Quality Assurance; or trained Pharmacovigilance Auditor
* Broad understanding of global expectations of Health Authorities in the management of clinical trials
* Profound understanding of the science of product development
* Knowledge of the national and international legislation as well as the guidelines concerning Pharmacovigilance
* Good communication skills and intercultural sensitivity
* Fluency in English
* Ability to travel up to 20%