Executive, Quality Management System (QMS)

QUALIFICATIONS:

• Bachelor’s Degree in Pharmacy, Life Sciences, Engineering or a related discipline; a relevant Master's degree or professional QMS/quality certification (e.g. Lead Auditor, CQE) is an added advantage.

EXPERIENCES:

• Minimum 3 years of progressive experience in Quality Assurance/QMS within a GMP-regulated (pharmaceutical or medical device) environment, including managing deviations, CAPA, change control and audits; prior leadership or supervisory experience preferred.

CHARACTERISTICS:

• Strong leadership and stakeholder management skills; strategic and analytical thinker with strong problem-solving ability; excellent communication and influencing skills; high level of integrity, decisiveness and ability to drive change across a matrixed organization.

JOB PURPOSE:

• To lead and manage the Company's Quality Management System (QMS) across both manufacturing and non-manufacturing scope, spanning the Company's pharmaceutical and medical device product lines, ensuring the QMS is effectively established, maintained and continuously improved in compliance with applicable GMP, regulatory and quality standards, thereby supporting organizational compliance, audit/inspection readiness and quality culture ahead of and following the sterile manufacturing plant's commissioning.

RESPONSIBILITIES:

1. QMS Leadership & Governance

• Lead and own the Company's Quality Management System framework across both manufacturing and non-manufacturing scope, ensuring alignment with GMP, ISO and applicable regulatory requirements.
• Chair/support management review meetings and quality council discussions, presenting QMS performance and trends to management.

2. Deviation & CAPA Management

• Oversee the deviation and CAPA management process, ensuring root cause investigations are robust and timely, and that corrective/preventive actions are effective and closed within defined timelines.
• Monitor recurring or systemic issues and escalate to management as needed.

3. Change Control Oversight

• Own and oversee the change control system, ensuring changes are appropriately assessed, approved and implemented with adequate risk evaluation.

4. Risk Management

• Lead quality risk management activities (e.g. FMEA, risk assessments) across QMS processes, ensuring risks are identified, evaluated and mitigated appropriately.

5. Document Control Oversight (QMS Scope)

• Provide leadership oversight of the QMS QADC's document control activities, ensuring the QMS documentation framework (SOPs, policies, forms) remains current and effective.

6. Audit & Inspection Readiness

• Lead preparation for internal and external audits/inspections relating to the QMS, act as key contact during inspections, and ensure timely closure of audit findings.
• Conduct or oversee internal audits/self-inspections as part of the QMS audit programme.

7. Continuous Improvement & Training

• Drive continuous improvement of QMS processes and systems, including digitalization and harmonization across manufacturing and non-manufacturing scope.
• Support QMS-related training and awareness programmes across the organization.

8. Plant Commissioning & Qualification Support

• Ensure the QMS is scaled and ready to support the sterile manufacturing plant's commissioning, qualification and start-up activities targeted for Q2 2027.

Pay: RM2,700.00 - RM4,000.00 per month

Benefits:

• Additional leave
• Dental insurance
• Flexible schedule
• Free parking
• Health insurance
• Maternity leave
• Meal allowance
• Opportunities for promotion
• Professional development
• Vision insurance

Ability to commute/relocate:

• Rawang: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Quality Assurance/QMS within a GMP-regulated: 3 years (Required)

Work Location: In person