Third Party Risk Lead, Sr. Manager

3 weeks ago

Tadworth, Surrey, United Kingdom Pfizer Full time
Third Party Risk Lead, Sr. Manager

Job Summary:

Pfizer is seeking a highly experienced Senior Manager to lead our Third Party Quality team. As a key member of our GCP Third Party Quality team, you will work closely with vendor leads and site organization stakeholders to ensure that clinical trial third party partners have the appropriate quality systems infrastructure.

Key Responsibilities:

  • Identify, evaluate, and respond to GCP quality risks related to vendor and site engagement.
  • Lead quality discussions with key vendors and sites, presenting a quality point of view at relevant oversight meetings.
  • Provide quality oversight reports to Pfizer management and functions.
  • Communicate key quality information across vendors and site entities, serving as a quality expert for third parties.
  • Validate, monitor, and close out GCP-quality-related action plans.
  • Evaluate quality performance at an enterprise level to inform continuous improvement of quality risk management.
  • Inform site organization relationship owners of quality improvement considerations.
  • Support QMS09 BPO in the development and implementation of process updates.
  • Support Vendor Leads/Business Owners to ensure compliance with functional level vendor oversight requirements.

Requirements:

Must-Have:

  • Bachelor's Degree.
  • Demonstrate extensive and relevant applicable experience in a similar role within the pharmaceutical industry.
  • Applicable pharmaceutical industry experience.
  • Robust knowledge in quality areas (i.e. audit, inspection, compliance, and inspection readiness fields).
  • Demonstrated project management/leadership experience.
  • Quality related experience including working knowledge in:
    • Quality and compliance management.
    • Root Cause Analysis.
    • Risk identification, controls, mitigations, and actions.
    • Metrics development and utilization.
    • Audit and Inspection conduct and CAPA response process.
  • Proficiency in Microsoft Office Suite.

Work Location Assignment: Flexible working is possible from Pfizer sites. Applicable sites: Walton Oaks (Tadworth, Surrey), Thessaloniki (Greece), Cambridge (UK), Sandwich (UK) or Canada.

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