QA Auditor – Life Sciences

BioTechTrek; Hinoba-an; On-site; PHP 400,000 - 700,000; Full time

Job summary

BioTechTrek is seeking a lead auditor to head routine and non-routine R&D Quality QA audits, ensuring strict compliance with internal standards and regulatory requirements.

您 will review safety information, data, and evidence, coordinate cross-functional audits across countries, and support regulatory inspections to maintain readiness.

Qualifications

• Experience conducting quality audits in regulated environments.
• Strong analytical thinking and attention to detail.
• Excellent communication and stakeholder management.
• Ability to review compliance evidence and safety data.

Responsibilities

• Lead the planning, execution, and reporting of routine R&D Quality QA audits.
• Support non-routine audits covering activities, data, facilities, processes, systems, and service providers.
• Assess adherence to corporate policies, internal quality standards, procedures, and applicable regulatory requirements.
• Support due diligence, for-cause, cross-functional, complex, and sensitive audits when required.
• Apply relevant standard operating procedures, diagnostic tools, and audit plans during audit activities.
• Support regulatory inspections in assigned roles and help maintain inspection readiness.

Skills

Analytical thinking

Attention to detail

Communication

Stakeholder management

Objective judgment

Problem solving

Data analysis

Compliance management

Internal controls

Quality management systems

Process-oriented thinking

Education

Bachelor’s degree or equivalent in a science/engineering or quality discipline

Job description

Lead the planning, execution, and reporting of routine R&D Quality QA audits.Support non-routine audits covering activities, data, facilities, processes, systems, and service providers.Assess adherence to corporate policies, internal quality standards, procedures, and applicable regulatory requirements.Support due diligence, for-cause, cross-functional, complex, and sensitive audits when required.Apply relevant standard operating procedures, diagnostic tools, and audit plans during audit activities.Support regulatory inspections in assigned roles and help maintain inspection readiness.

Required Skills

The ideal candidate should demonstrate strong analytical thinking and attention to detail

particularly when reviewing safety information and compliance evidence.Important competencies include communication and stakeholder management

objective judgment

problem solving

data analysis

compliance management

internal controls

quality management systems (QMS)

quality standards

and process-oriented thinking.Candidates should also be comfortable working cross-functionally and across different countries and geographies while managing multiple audits and competing priorities.