Quality Compliance lead
On-siteAlgeria, Zamboanga Peninsula, Republic of the Philippines
Job Summary
Conduct GMP standards compliance audits and investigations while managing inspection readiness and data integrity program improvements. Lead training system oversight by managing GMP curricula, assessments, and LMS records, and drive supplier qualification through internal audits and agreement management. Oversee change controls, CAPA reviews, and continuous improvement initiatives across quality systems. Requires a Bachelor's degree in a scientific discipline, fluent French and English, and minimum five years in pharmaceutical quality systems. Reports to the Site Quality Lead with interactions across the global network.
Required Qualifications
- Bachelor's Degree, Master 's Degree, PharmD, or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, Engineering, or a related scientific discipline.
- Fluent in French and English, both written and verbal.
- Minimum 5 years of experience in the pharmaceutical industry within Quality Systems including more than 2 years within Quality Compliance.
- Proven experience managing Quality Systems including Data Integrity, Training, Supplier management and qualification, and Documentation Management.
- Experience supporting regulatory inspections, internal audits, external audits, and inspection readiness activities.
- Demonstrated ability to work effectively in cross-functional and matrix organizations while influencing stakeholders at different levels.
- Experience leading quality and compliance improvement initiatives and driving a culture of compliance and continuous improvement.
- Strong knowledge of cGMP, and Data Integrity principles (ALCOA+).
- Experience with electronic Quality Management Systems (eQMS), TrackWise, gQTS, and document management systems, Supplier management system.
- Ability to perform compliance assessments, quality trend analysis, and risk-based decision making.
- Strong technical writing skills for procedures, investigation reports, Change Control, risk assessments, and audit responses.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Teams, and SharePoint).
- Strong communication, project management, and stakeholder management skills.
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