Senior PV QA Lead - QMS & CAPA Excellence

OrciMed Life Sciences Philippines OPC; Metro Manila; On-site; PHP 1,000,000 - 1,800,000; Full time

Job summary

OrciMed Life Sciences Philippines OPC is seeking a QA Lead to drive Pharmacovigilance quality and regulatory compliance. You will provide strategic direction to the QA team, oversee audits and CAPA, and champion continuous improvement across the organization.

The role requires 12+ years in Pharmacovigilance QA, a degree in Pharmacy or Life Sciences, hands-on GxP/GVP experience, and proven leadership. You will develop QA policies and manage deviations, investigations, and vendor/client audits.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Medicine, or related discipline.
• 12+ years of relevant experience, with substantial Pharmacovigilance Quality Assurance background.
• Prior experience managing a QA team is required.
• Strong hands-on experience in GxP/GVP compliance and audits.

Responsibilities

• Lead and manage the Quality Assurance function for Pharmacovigilance operations.
• Establish and continuously improve the Quality Management System (QMS).
• Ensure compliance with regulatory requirements, client requirements, and internal standards.
• Develop QA policies, SOPs, work instructions, and quality plans.
• Plan, coordinate, and execute internal quality audits and assessments.
• Support client audits, vendor audits, and regulatory inspections.
• Oversee deviation, investigation, CAPA, and effectiveness checks.
• Provide QA oversight for PV activities including case processing and signal management.
• Lead, mentor, and develop the QA team.
• Identify opportunities to improve quality processes and efficiency.

Job description

OrciMed Life Sciences Philippines OPC is seeking a QA Lead to drive Pharmacovigilance quality and regulatory compliance. You will provide strategic direction to the QA team, oversee audits and CAPA, and champion continuous improvement across the organization.

The role requires 12+ years in Pharmacovigilance QA, a degree in Pharmacy or Life Sciences, hands-on GxP/GVP experience, and proven leadership. You will develop QA policies and manage deviations, investigations, and vendor/client audits.