Job Title: Quality Manager, Global Quality Management
Location: UK (preferably located near Windsor)
Are you a Pharmacovigilance professional with a keen eye for quality management?
Do you possess experience in audits, inspections, and CAPA management, and aspire to transition into a broader Quality role?
We have an exciting opportunity for you to join our Global Quality Management team as a Quality Manager.
Role Overview:
As a Quality Manager, your primary responsibility will be to support the Global Quality Management team, focusing on Pharmacovigilance Audit coordination.
While this position isn't strictly an auditing role, it offers a pathway for you to progress into a PV auditing role in the future.
This is a hybrid role with the expectation of global travel, requiring flexibility and a commitment to excellence.
Key Responsibilities:
* Coordinate and manage Pharmacovigilance Audit activities.
* Facilitate audit preparation meetings and maintain the Master Audit Schedule tracker.
* Oversee the development, implementation, and closure of corrective and preventive actions.
* Assist in planning, documenting, and executing the Pharmacovigilance Audit strategy.
* Support risk assessment activities and contribute to the preparation and review of Audit Reports.
* Collaborate with Functional Area representatives to enhance the Quality System.
* Drive continuous improvement initiatives within the organization.
* Assist in preparation for regulatory inspections and contribute to responses to Regulatory Authorities.
* Manage ACE Chat, Scribe Notes, and other assigned activities.
Qualifications/Experience:
* Bachelor's degree in the sciences (BSc)
* Minimum of 2 years' experience in the pharmaceutical industry, preferably in a Pharmacovigilance role
* Proficiency in CAPA management
* Exposure to regulatory inspections
* Understanding of regulations and guidance related to clinical development
* Knowledge of Good Pharmacovigilance Practice processes
* Familiarity with audits and CAPA management
* Ability to work independently and collaboratively within a quality team
* Advanced proficiency in MS Office, particularly Excel & PowerPoint; knowledge of TrackWise and ACE is desirable
* Excellent written and oral communication skills in English
* Strong problem-solving, analytical, and creative thinking abilities
* Understanding of risk-based prioritization methodologies
How to Apply:
If you are ready to take the next step in your career and contribute to global quality management in the pharmaceutical industry, please submit your CV and cover letter highlighting your relevant experience and why you are the ideal candidate for this role.
Join us in making a difference in global healthcare through quality excellence. Apply now!
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