Quality Assurance Lead

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

About the role

The QA Lead will be responsible for ensuring compliance with applicable regulatory requirements, client expectations, internal procedures, and quality standards. The role will provide strategic direction to the QA team, oversee audits and inspections, manage CAPA and deviations, and drive continuous improvement across the organization.

Key responsibilities

• Lead and manage the Quality Assurance function for Pharmacovigilance operations
• Establish, implement, and continuously improve the organization's Quality Management System (QMS)
• Ensure compliance with applicable regulatory requirements, client requirements, and internal quality standards
• Develop and maintain QA policies, SOPs, work instructions, quality plans, and related documentation
• Plan, coordinate, and execute internal quality audits and assessments
• Support and coordinate client audits, vendor audits, and regulatory inspections
• Oversee the deviation, investigation, CAPA, and effectiveness-check processes
• Provide QA oversight for PV activities including case processing, triage, data entry, quality review, literature surveillance, aggregate reporting, and signal management
• Lead, mentor, and develop the QA team
• Identify opportunities to improve quality processes and operational efficiency

About you

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Medicine, or a related discipline
• 12+ years of relevant experience, with substantial experience in Pharmacovigilance Quality Assurance
• Prior experience managing a QA team is required
• Strong hands-on experience in Pharmacovigilance Quality Assurance, GxP / GVP compliance, internal and external audits, client audits and regulatory inspections
• Strong hands-on experience in CAPA management, deviation and investigation management, root cause analysis, and SOP and controlled document management
• Strong understanding of global Pharmacovigilance regulations and quality standards
• Strong analytical and problem-solving skills
• Excellent written and verbal communication
• Strong stakeholder management skills
• Strong leadership and people-management skills