Quality Systems & Compliance Engineer - #1133133

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, etc.

• Strong learning ability.

• Effective at cross-functional communication and collaboration.