QA and Regulatory Manager

Precisione International Research and Diagnostic Laboratory Inc.; Marilao; On-site; PHP 600,000 - 900,000; Full time

Job summary

Precisione International Research and Diagnostic Laboratory Inc. seeks a QA & Regulatory Manager to lead the Quality Management System and ensure compliance with regulatory and accreditation standards.

The role drives continuous improvement across the organization, oversees audits, permits, and submissions, and mentors teams to maintain objective, evidence-based quality decisions.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, or related field.
• 3–5 years of relevant QA, regulatory, or laboratory experience preferred.
• Knowledge of ISO/IEC 17025:2017 highly preferred.
• Experience with laboratory accreditation and regulatory compliance is an advantage.
• Strong leadership, analytical, communication, and problem-solving skills.
• Detail-oriented, organized, and able to work independently and collaboratively.

Responsibilities

• Maintain and improve the Quality Management System (QMS) based on ISO/IEC 17025:2017.
• Ensure compliance with PAB, FDA, DOH, BAI, and other applicable regulatory requirements.
• Lead preparations for internal, external, and regulatory audits.
• Monitor permits, licenses, accreditations, and regulatory submissions.
• Manage audit findings, nonconformities, root-cause analysis, and corrective actions.
• Oversee document and records control.
• Monitor quality and regulatory risks and recommend appropriate actions.
• Ensure quality decisions remain objective, independent, and evidence-based.
• Provide management with regular quality and compliance updates.
• Promote continuous improvement and a strong quality culture.

Skills

Leadership

Analytical thinking

Communication

Problem solving

Detail-oriented

Organized

Independent work

Collaborative

Education

Bachelor's degree in Chemistry, Microbiology, or related field

Job description

About the role

The QA & Regulatory Manager is responsible for ensuring the laboratory's compliance with quality standards, regulatory requirements, and accreditation requirements. The role leads the Quality Management System and supports continuous improvement across the organization.

Key responsibilities

• Maintain and improve the Quality Management System (QMS) based on ISO/IEC 17025:2017.

• Ensure compliance with PAB, FDA, DOH, BAI, and other applicable regulatory requirements.

• Lead preparations for internal, external, and regulatory audits.

• Monitor permits, licenses, accreditations, and regulatory submissions.

• Manage audit findings, nonconformities, root-cause analysis, and corrective actions.

• Oversee document and records control.

• Monitor quality and regulatory risks and recommend appropriate actions.

• Ensure quality decisions remain objective, independent, and evidence-based.

• Provide management with regular quality and compliance updates.

• Promote continuous improvement and a strong quality culture.

About you

• Bachelor's degree in Chemistry, Microbiology, or related field.

• Preferably with 3–5 years of relevant QA, regulatory, or laboratory experience.

• Knowledge of ISO/IEC 17025:2017 is highly preferred.

• Experience with laboratory accreditation and regulatory compliance is an advantage.

• Strong leadership, analytical, communication, and problem-solving skills.

• Detail-oriented, organized, and able to work independently and collaboratively.