Head of Quality Assurance

Malaysian Genomics Resource Centre Berhad; Petaling Jaya; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading biotechnology company in Petaling Jaya is seeking a Quality Assurance Manager to oversee the Pharmaceutical Quality System and ensure compliance with GMP and ISO standards. The ideal candidate will have at least 5 years of experience in a QA-regulated environment, with strong leadership and decision-making skills. This role involves managing quality audits, training staff, and maintaining documentation integrity within the quality management systems.

Qualifications

• Minimum 5 years of experience in a QA-regulated industry.
• At least 3 years in a Quality Assurance leadership or supervisory role.

Responsibilities

• Establish and maintain the Pharmaceutical Quality System.
• Ensure compliance with GMP, ISO, and regulatory requirements.
• Review and approve quality-related documents.

Skills

Strong understanding of GMP, ISO, QMS, and regulatory requirements

Excellent leadership

Communication skills

Decision-making skills

Meticulous with documentation

Effective cross-functional coordination

Education

Bachelor’s or Master’s Degree in Pharmacy, Biotechnology, Life Sciences, or related field

Job description

Overview

1. Establish, implement, and maintain the Pharmaceutical Quality System (PQS) and quality management systems (QMS) as adopted by the company.
2. Ensure that cell productions and quality operations comply with GMP and ISO and regulatory requirements.
3. Review and approve all quality-related documents, including SOPs, batch records, validation protocols/reports, and deviations.
4. Responsible for the release or rejection of intermediate and finished products in accordance with GMP, ISO and quality standards. Ensure that product batches are not released until their quality has been verified and meets specifications.
5. Oversee deviation management, CAPA, change control, documentation management, and complaint handling systems.
6. Coordinate periodical management reviews.
7. Coordinate and conduct internal quality audits.
8. Coordinate external inspections by regulators, certification bodies, and customers, as required.
9. Be the principal trainer for GMP, ISO and quality related topics.
10. Ensure the monitoring of trends and data to identify areas for improvement within the PQS.
11. Ensure control over suppliers and contract manufacturers through audits and quality agreements.
12. Collaborate with the Head of Cell Production and Head of Quality Control on quality-related decisions.
13. Participate in quality risk assessments and implementation of mitigation plans.
14. Maintain data integrity throughout all Quality Assurance processes.
15. Manage the Quality Assurance team, including performance evaluation and training.
16. Attend adequate training sessions prior to performing any assigned tasks or whenever required.
17. Undertake other relevant duties assigned by Management, as necessary.

Requirements

1. Academic Qualifications: Bachelor’s or Master’s Degree in Pharmacy, Biotechnology, Life Sciences, or related field.
2. Experience: Minimum 5 years of experience in a QA-regulated industry, with at least 3 years in a Quality Assurance leadership or supervisory role.

• Strong understanding of GMP, ISO, QMS, and regulatory requirements.

• Excellent leadership, communication, and decision-making skills.

• Able to manage audits and cross-functional coordination effectively.

• Meticulous with documentation and quality systems.