Senior Manager PV Quality

Senior Manager PV Quality

Daiichi Sankyo Europe

Munich, Germany

Purpose of the function:

The Senior Manager PV Quality will participate in the implementation of the quality strategy closely aligned with the business strategy within the CSPV function. As an ad hoc member the incumbent will provide strategic and proactive QA Leadership. This role will advise development teams in quality and compliance decision making to drive sustainable quality and compliance excellence.

Responsibilities:

• Facilitate the implementation of the quality strategy in close alignment with the CSPV business strategy;
• Support the Head of PV QA, Europe/Global PV Quality with Quality Reviews of respective product profile;
• Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process;
• Effectively communicate with CSPV, by interacting with other GxP QA functions on CSPV topics/issues impacting the respective Pharmacovigilance operations and safety activities;
• Collaborate with CSPV and Global PV Quality on quality review of PV System and documents;
• Help to ensure that applicable CSPV processes and quality standards are in line with worldwide HA requirements;
• Quality Oversight:
  • Ensure adequate and timely escalation of incidents/issues within CSPV 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.
• In collaboration with CSPV develop Lessons learned information flow at the CSPV operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement;
• Ensure continued submission and inspection readiness for the respective CSPV team and related submissions.

Education Qualifications (from an accredited college or university):

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required;
• Master's Degree advanced degree in Life Sciences, Pharmacy or Medicines preferred.

Experience Qualifications:

• 5 or More Years of involvement in in the area of PV Quality Assurance; or trained PV 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 PV;
• Good communication skills and intercultural sensitivity;
• Very good English language skills;
• Ability to travel up to 20%.

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