Senior Director, Data Management

2 weeks ago


Oxford, Oxfordshire, United Kingdom CTI Clinical Trial and Consulting Services Full time
Job Summary

Jazz Pharmaceuticals plc is seeking a Senior Director, Data Management to lead the Clinical and Pharmacovigilance Quality Assurance function. The successful candidate will ensure that all aspects of the global Jazz clinical and pharmacovigilance business meets regulatory quality and GXP compliance expectations.

Key Responsibilities
  1. Develop and implement the global Quality strategy, as relevant to GcP/GPvP across the clinical development business.
  2. Contribute to the setting of long-term goals and priorities to ensure the business achieves and maintains the company's Quality strategy.
  3. Influence senior leadership in support of Quality intent and strategy.
  4. Ensure preparedness for inspections, identification of compliance vulnerabilities and to develop responses for inspectional observations.
  5. Verify that data integrity principles are adhered to within clinical development and pharmacovigilance activities.
  6. Strategically assess and report to the Vice President, Quality and Corporate Senior Management, the risk of any critical or major audit finding identified at any study specific, Vendor, Marketing Partner or internal process/system audit.
  7. Promote quality by design awareness amongst company personnel and develop and maintain company GCP, cGLP, GLP GPvP and other quality standards by means of training, review, advice and guidance services.
  8. Manage and support activities for Company and Clinical Investigator inspections/external audits (GCP GPvP) conducted by national and international regulatory authorities (RA) and other external bodies such as marketing partners by acting as Inspection Lead/Host.
Requirements

Substantial and relevant experience (typically 16+ years) in the pharmaceutical or biotechnology industry. Substantial and relevant experience (typically a minimum of 7 years) in Quality leadership roles, including experience in GCP/GPvP cGLP.

Working knowledge of office IT packages, working knowledge of eQMS, and a very high level of written and verbal communication skills.

Minimum of a Bachelors degree required in a science discipline or other relevant field. Post-graduate (Masters/PhD) preferred.



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