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.
Work mode: Office based
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.
How to Apply:
Please provide your CV to Shash Prasanan at shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document/pdf format.
