Head of Quality (QC & QA)

ATOMRecruit; Malacca City; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading pharmaceutical manufacturer in Malacca is seeking a Head of Quality to oversee the QC & QA functions. This role requires strategic leadership, ensuring compliance across the product lifecycle from raw material inspection to final release, with a team of 80-90 professionals. Candidates should have substantial experience in pharmaceutical quality, regulatory inspections, and strong leadership skills.

Qualifications

• Minimum 10–15 years of experience in pharmaceutical quality.
• At least 5 years in a senior QA/QC leadership position.
• Proven experience in regulatory inspections.

Responsibilities

• Provide strategic direction for Quality Assurance and Control teams.
• Ensure compliance with GMP, GDP, and regulatory standards.
• Manage and mentor QA/QC teams.

Skills

Leadership

Stakeholder Communication

Problem Solving

Education

Bachelor’s or Master’s Degree in Pharmacy, Chemistry, Microbiology or related science

Job description

Head of Quality (QC & QA) (1531) Malacca, Malaysia

We are currently looking for a Head of Quality to lead the QC &QA function for a leading pharmaceutical manufacturer committed to delivering high-quality, affordable generics and specialty medications. With a strong manufacturing presence and distribution footprint across Southeast Asia, the company is focused on regulatory compliance, operational excellence, and continuous improvement to serve both local and international markets.As the Head of QA/QC, you will lead the Quality function across the entire product lifecycle—from raw material inspection to final batch release. This role is critical in ensuring cGMP, regulatory, and quality compliance for both local (NPRA) and export (PIC/S, WHO GMP) markets.

Reporting to: General Manager

Team Size:80-90 QA/QC professionals across validation, in-process QA, laboratory QC, documentation, and compliance.

Culture: Looking for a leader and someone to coach, mentor and inspire the team and fosters collaboration.

The Role:-

• Provide strategic direction and leadership for Quality Assurance and Quality Control teams.
• Ensure site-wide compliance with GMP, GDP, and regulatory standards (NPRA, WHO, PIC/S, ASEAN, etc.).
• Lead internal audits, regulatory inspections, and customer audits; develop and track CAPAs.
• Oversee product quality review, change control, deviation, OOS, and recall systems.
• Manage and mentor QA and QC teams, including training, performance evaluation, and development planning.
• Drive continuous improvement initiatives using risk-based approaches and QMS best practices.
• Collaborate closely with manufacturing, regulatory affairs, and R&D teams to ensure product quality and launch readiness.

The Experience:-

• Bachelor’s or Master’s Degree in Pharmacy, Chemistry, Microbiology or a related science field.
• Minimum 10–15 years of experience in pharmaceutical quality, with at least 5 years in a senior QA/QC leadership position.
• Proven experience in regulatory inspections (e.g., NPRA, WHO, ASEAN, GCC, PIC/S).
• Strong knowledge of ICH Q-series, GMP guidelines, and QMS implementation.
• Expertise in batch release, validations, documentation control, and laboratory operations.
• Familiarity with sterile, non-sterile, and high-potency manufacturing environments is a plus.
• Excellent stakeholder communication, leadership, and problem-solving abilities.

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Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.