Job Summary
Establish an effective quality management system and ensure it runs smoothly.
Responsibilities
- Oversee the establishment and maintenance of an effective quality system, ensuring full compliance with the latest regulatory requirements.
- Manage the entire GMP documentation lifecycle (creation/retired, revision, review, issuance, archiving and destruction), ensuring accuracy and control.
- Be responsible for personnel training initiatives.
- Oversee quality events management (deviation, CAPA, change control), ensuring all changes are thoroughly assessed before implementation.
- Conduct regular reviews and assessments of quality metrics to ensure continuous improvement, including trend analysis of quality processes (deviation, CAPA, change control, complaints etc.).
- Establish and implement a comprehensive Quality Risk Management Plan, ensuring timely execution and tracking mitigation efforts (if any) to completion.
- Facilitate regular quality management review meetings in accordance with internal policies.
- Take charge of regulatory surveillance and compliance, continuously monitoring regulatory changes, including but not limited to FDA, EMEA, PIC/S, cGMP, HSA and other relevant guidelines. Lead gap assessments and ensure timely implementation of necessary updates.
- Lead internal audit program by developing audit plan.
- Lead external audits and response to client / regulatory audits and coordinate CAPA implementation.
- Oversee the supplier management program, including quality activities such as supplier qualification (audit and assessment), periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements to ensure compliance.
- Handle product complaints efficiently.
- Manage product recalls when necessary.
- Perform other tasks assigned by leadership.
Qualifications
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in production QA, quality system QA or compliance QA.
- Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
- Experience in setting up quality systems for new sites is preferred.
- Experience in leading audits is preferred.
- Experience with biopharma commercial quality systems is preferred.
- Proficient in English listening, speaking, reading, and writing.
- Skilled in Microsoft Word, Excel, PowerPoint, TrackWise, SAP etc.
- Strong learning ability.
- Effective at cross-functional communication and collaboration.
