Quality Manager

This is a fully remote position, open to applicants in Serbia, +6 more countries.

📋 Description

• Implement the Pharmacovigilance Quality Management System within the Global Patient Safety function.

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

• Oversee the execution and maintenance of the Comprehensive Training Program.

• Manage activities related to GPS procedural documentation.

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

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

• Assist with or oversee GVP audit and inspection initiatives.

• Prepare GPS team members for inspection readiness, ensuring that inspection documents are easily accessible.

• Coordinate and formulate GPS responses to audit and inspection results.

• Analyze issue-management trends and implement strategies to mitigate systemic issues.

• Identify internal discrepancies and support corrective and preventive measures, including root-cause analysis.

• Lead the execution of corrective or preventive measures in collaboration with the client Quality functional area.

• Develop, maintain, expand, and deliver pharmacovigilance training programs.

• Aid in monitoring and updating the GPS training curriculum.

• Provide training to pertinent client employees and third parties when necessary.

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

• Participate in cross-functional activities and forums related to procedural documents.

• Assist with document control utilizing the Veeva system.

• Contribute to the development and assessment of key performance indicators.

• Monitor adherence to third-party contractual obligations, PVAs, SDEAs, and other agreements.

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

• Ensure compliance with GPS SOPs and controlled documents.

• Perform other tasks as assigned by the line manager or GPS Leadership.

⛳️ Requirements

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

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

• A minimum of 3 years of experience in a related pharmacovigilance or drug safety role.

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

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

• Working knowledge of pertinent pharmacovigilance regulatory requirements and guidance documents, including those from Europe, the US, and Japan.

• Familiarity with GXP quality and compliance requirements, processes, and measures.

• Exceptional planning and organizational abilities.

• Strong oral and written communication skills.

• Capability to operate in a global environment.

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

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

• Demonstrated skill in authoring and contributing to procedural documents.

• Ability to inspire and collaborate with multidisciplinary teams.

• Proficient in Microsoft Office and tracking databases.

• Fluency in both written and spoken English.

🏝️ Benefits

• Fully remote work arrangement.