Third Party Risk Lead, Sr. Manager
4 weeks ago
We're a global pharmaceutical company dedicated to delivering innovative treatments and improving patient outcomes. As a Third Party Risk Lead, Sr. Manager, you'll play a critical role in ensuring the quality and integrity of our clinical trials.
About the RoleAs a member of our GCP Third Party Quality team, you'll work closely with vendor leads and site organization stakeholders to identify, evaluate, and respond to GCP quality risks related to vendor and site engagement. Your advanced knowledge of quality management principles and concepts will enable you to lead complex projects and develop effective plans to achieve objectives.
Key Responsibilities- Identify and evaluate GCP quality risks related to vendor and site engagement.
- Lead quality discussions with key vendors and sites, presenting quality points 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.
- Bachelor's Degree.
- Extensive and relevant applicable experience in a similar role within the pharmaceutical industry.
- Applicable pharmaceutical industry experience.
- Robust knowledge in quality areas, including 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, audit and inspection conduct, and CAPA response process.
- Proficiency in Microsoft Office Suite.
We offer a competitive compensation and benefits package, as well as a flexible working environment that allows for work-life harmony. We're committed to creating a trusting and inclusive workplace culture that celebrates diversity and promotes employee well-being.
We're proud to be a Disability Confident Employer and encourage applicants with disabilities to apply. We'll make reasonable adjustments necessary to support your application and future career.
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