Quality Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Implement the Pharmacovigilance Quality Management System within the Global Patient Safety (GPS) division.

• Assist in the development and enhancement of the GPS Quality Management function.

• Oversee and execute the Comprehensive Training Program.

• Manage activities related to GPS procedural documentation.

• Engage in GPS audit preparation and inspection readiness, providing support and management.

• Drive continuous improvement initiatives through issue management, process enhancement, and KPI development.

• Support and/or lead GVP audit and inspection activities.

• Prepare GPS team members for inspection readiness tasks.

• Ensure that inspection documents are accessible and up-to-date.

• Coordinate and prepare GPS responses to audit and inspection outcomes.

• Analyze issue-management trends and develop action plans to address systemic causes.

• Identify deviations and assist in determining corrective and preventive actions.

• Facilitate root-cause analysis and lead the implementation of corrective or preventive actions in collaboration with the client Quality function.

• Create, maintain, enhance, and deliver pharmacovigilance training programs.

• Support the monitoring, maintenance, reevaluation, and updates of the training curriculum.

• Provide training to relevant client personnel and third parties as necessary.

• Develop, review, and continuously enhance GPS processes and procedures.

• Participate in cross-functional procedural document forums, providing GPS input and review.

• Assist with document control utilizing the Veeva system.

• Establish and evaluate KPIs in line with evolving business requirements.

• Ensure compliance with third-party contractual obligations, including PVAs, SDEAs, and other agreements.

• Collaborate with the QA Department regarding GPS quality and compliance requirements and deliverables.

• Monitor adherence to GPS SOPs and controlled documents.

• Perform additional duties as assigned by the line manager or GPS Leadership.

• Report to the Associate Director, GPS Quality Management or higher.

⛳️ Requirements

• Bachelor’s degree in pharmacy, nursing, healthcare, another life-science or technical field, or an equivalent combination of education and experience.

• Minimum of 5 years of experience in the pharmaceutical or biotech industry.

• At least 3 years of experience in a relevant pharmacovigilance or drug safety role.

• Proven track record in managing pharmacovigilance quality systems, processes, and teams.

• Experience in preparing for, conducting, and responding to audits and regulatory inspections on a global scale.

• Familiarity with pertinent pharmacovigilance regulatory requirements and guidance documents, including those from Europe, the US, and Japan.

• Understanding of GXP quality and compliance standards, processes, and metrics.

• Exceptional planning and organizational abilities.

• Strong oral and written communication skills.

• Capability to work effectively in a global setting.

• Solution-oriented with the ability to prioritize tasks and work independently.

• Strong presentation skills and the ability to articulate complex issues clearly.

• Demonstrated experience in authoring and contributing to procedural documents.

• Ability to inspire and collaborate with multidisciplinary teams.

• Proficient in Microsoft Office and tracking databases.

• Fluent in both written and spoken English.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.