Job Title: Senior Quality Specialist / Auditor (Life Sciences / GxP)
Salary: 75,000-90,000 PHP
Shift: Should be amenable to work day shift or night shift.
Role Overview
As a Senior Quality Specialist, you will play a critical role in delivering high-impact quality consulting and compliance support to life sciences clients. You will lead quality system assessments, gap analyses, audits, remediation planning, and cross-functional compliance projects. You will work directly with senior leadership and clients to ensure alignment with global regulations, GxP standards, and industry best practices.
Key Responsibilities
- Lead assessments of quality systems and operational processes against GxP requirements (GCP, GMP, GLP, GDP) and global regulations
- Support development, implementation, and remediation of Quality Management Systems (QMS)
- Conduct and lead internal and external quality audits, clinical site audits, vendor audits, and readiness assessments
- Interpret and apply regulatory requirements including:
- ICH E6(R3) Good Clinical Practice
- ISO 14155 Clinical Investigation Standard
- 21 CFR Part 312 (IND Requirements)
- 21 CFR Part 812 (IDE Requirements)
- 21 CFR Part 211 (Pharmaceutical GMP)
- 21 CFR Part 820 (Medical Device QMS)
- Collaborate with cross-functional teams to develop corrective and preventive actions (CAPAs), remediation plans, and quality improvement initiatives
- Prepare high-quality deliverables including audit reports, gap analysis summaries, compliance strategy documents, and training content
- Guide clients in regulatory inspection preparedness and mock inspection scenarios
- Provide education and training on quality system requirements, regulatory expectations, and industry standards
- Serve as a subject-matter expert (SME) for regulatory interpretation and complex compliance challenges
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Quality Assurance, Regulatory Affairs, or related field
- Minimum 710+ years of quality assurance experience in clinical or pharmaceutical/medical device environments
- Proven experience with clinical quality systems and compliance (ICH, GCP, etc.)
- Strong working knowledge of:
- ICH E6(R3) and GCP/GLCP principles
- ISO 14155 clinical investigation standard
- FDA regulations: 21 CFR 312, 812, 211, 820
- Global regulations and quality system standards (e.g., ICH E10, Q9, EMA, China, Korea, Japan, EU MDR, IVDR, ISO 13485)
- Experience conducting and leading quality audits and assessments
- Quality / Auditor certification such as:
- ASQ Certified Quality Auditor (CQA) or equivalent
- Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred
- Demonstrated ability to lead cross-functional initiatives and mentor junior staff
- Strong communication, presentation, and technical writing skills
Preferred Attributes
- Prior consulting experience in life sciences (clinical trials, medical devices, biologics, pharma)
- Experience working with regulatory agencies or participating in regulatory inspections
- Familiarity with electronic QMS and audit management tools
