GPS Quality Manager

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

📋 Description

• Lead the expansion of the GPS Quality Management function

• Execute and manage the Comprehensive Training Program

• Oversee GPS Procedural Document initiatives

• Actively engage in and coordinate GPS Audit & Inspection Readiness, Support & Management

• Propel GPS Continuous Improvement (Issue Management, Process enhancement, KPI development)

• Organize and supervise GVP Audit & Inspection efforts

• Participate in the internal global GVP audit program and activities for inspection readiness

• Prepare GPS team members for inspection readiness initiatives

• Analyze trends in GPS issue management and create/implement action plans to address systemic causes

• Assist the GPS team in identifying the root causes of issues to prevent recurrence

• Develop, enhance, and deliver the pharmacovigilance training program

• Oversee GPS Procedural Document activities, including contributing to, developing, reviewing, and continually refining GPS processes & procedures.

⛳️ Requirements

• Minimum of a Bachelor’s degree in pharmacy, nursing, healthcare, or another life-science or technical field

• At least 7 years of experience in the pharmaceutical/biotech sector with a minimum of 5 years in a relevant pharmacovigilance/drug safety role

• Demonstrated success in establishing or managing pharmacovigilance quality systems, processes, and teams

• Extensive experience in preparing for, conducting, and responding to audits and regulatory inspections worldwide

• Strong working knowledge of pertinent pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)

• In-depth expertise in GXP quality and compliance requirements, processes, and measures.

🏝️ Benefits

• Comprehensive benefits package, inclusive of health benefits

• Retirement savings plans

• Short-term and long-term incentive programs