Full-Time Senior Quality Assurance Manager

Position Summary: The Senior Quality Assurance Manager ensures continuous quality improvement through effective management and oversight of Audits and Inspections.

Roles and Responsibilities:

• Leads a team which manages audit and inspection findings and CAPAs.
• Manages and maintains the electronic quality management system (EG-QMS) Audits module - CAPA Management.
• Performs periodic trending of Findings across the company.
• Fosters a culture of quality within the organization.
• Participates in audits and inspections.
• Acts as a Subject Matter Expert and client point-of-contact for Quality.
• Collaborates and guides operational personnel to ensure effective root cause analysis and CAPA Plans.
• Generates metrics on CAPA compliance.
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations.
• Conducts other ad hoc activities as requested.

Specified Additional Responsibilities:

• Procedural creation, management revision.
• Training.
• Analysis and reporting of quality related data.
• Effective operational line management of direct reports.

• Ensures the timely delivery of performance reviews.
• Absence approval management and resource planning.
• Ensuring adequate cover to meet operational requirements.
• Mentoring and training aligned to development needs.

Requirements:

• A university degree in a healthcare discipline or equivalent scientific area
• Substantial experience in pharmaceutical/biotechnology pharmacovigilance.
• Sound knowledge of international regulations related to Pharmacovigilance and Medical Information.
• Experience of participating in audits and inspections.
• Ability to lead, mentor, and develop teams.
• Excellent communication and facilitation skills.
• Proactive and self-motivated with strong organizational and planning abilities.
• Excellent problem-solving and decision-making skills.
• Attention to detail and commitment to high standards.
• Ability to analyze data and prepare detailed reports.
• Knowledge of quality management principles and practices.

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