Senior Quality Assurance Specialist

What you'll do:

As a Senior Quality Assurance Specialist based in Kuala Lumpur, you will be entrusted with overseeing the implementation and enhancement of robust quality systems throughout Southeast Asia. Your day-to-day responsibilities will involve collaborating closely with local affiliates, supply chain partners, regulatory affairs professionals, and commercial teams to embed quality into every aspect of operations. You will play an instrumental role in managing CAPA processes, supporting audit readiness efforts, coordinating recall activities when necessary, handling customer complaints with care, evaluating product returns or recalls for appropriate action, approving critical subcontracted activities impacting compliance standards, assisting with licensing matters, conducting supplier audits, delivering impactful training sessions to foster a culture of continuous learning, tracking key performance indicators for data-driven decision-making, and acting as a trusted regional point of contact for both global initiatives and local projects. Success in this position requires not only technical proficiency but also strong interpersonal skills to build consensus among diverse stakeholders while upholding the highest standards of integrity.

• Implement, maintain, and continuously improve the regional Quality Management System (QMS) in alignment with global Good Distribution Practice (GDP) standards and local regulations.
• Oversee Corrective and Preventive Actions (CAPA), deviation management, and change control processes to ensure effective resolution and compliance across all operational areas.
• Coordinate recall operations for therapeutic or medical device products promptly and efficiently, safeguarding patient safety at every stage.
• Manage customer complaints by ensuring they are addressed thoroughly and effectively, maintaining high levels of satisfaction and trust.
• Evaluate the disposition of returned, rejected, recalled, or counterfeit products through detailed analysis and risk assessment procedures.
• Ensure suppliers and customers are legally approved or authorised for the lawful supply of therapeutic products and medical devices within the region.
• Approve subcontracted activities that may impact Good Manufacturing Practice (GMP) or GDP compliance, ensuring all third-party engagements meet stringent quality requirements.
• Support applications, renewals, and maintenance of regulatory licenses such as GDP, ISO13485, or GMPMD certificates by liaising with local teams and regulatory authorities.
• Conduct or support supplier qualification audits while monitoring the performance of third-party logistics providers and service vendors to uphold quality standards.
• Develop and deliver quality-related training programmes for cross-functional teams, ensuring ongoing compliance with initial and continuous training requirements.

What you bring:

The ideal candidate for the Senior Quality Assurance Specialist position brings substantial hands-on experience from regulated industries such as pharmaceuticals or medical devices. Your background includes direct involvement with international quality standards like GDP/GMP/ISO 13485/ GDPMD alongside practical exposure to electronic QMS platforms. You possess excellent written and verbal communication skills which enable you to connect meaningfully with colleagues from various cultural backgrounds. Your proven ability to manage complex projects across multiple countries demonstrates your adaptability while your meticulous approach ensures nothing is overlooked during audits or process reviews. You thrive when working collaboratively within cross-functional teams yet remain dependable when independently driving initiatives forward. Your willingness to travel regionally reflects your commitment to supporting both local affiliates’ needs as well as broader organisational objectives.

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, Biotechnology, Engineering or related field; an advanced degree such as MSc or MBA is advantageous but not essential.
• At least five years’ experience in Quality Assurance roles within healthcare or life sciences sectors—preferably covering multiple countries within Southeast Asia.
• Demonstrated knowledge of GDP (Good Distribution Practice), GMP (Good Manufacturing Practice), ISO 13485 & GDPMD standards relevant to pharmaceutical distribution or medical devices.
• Proven track record managing QMS principles including CAPA processes, deviation management protocols, change control systems and document management tools such as TrackWise or Veeva.
• Experience preparing for internal/external audits—including supplier audits—and responding effectively to health authority inspections across different jurisdictions.
• Familiarity with regulatory environments spanning Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Taiwan or Hong Kong is highly desirable.
• Excellent communication abilities in English; additional regional languages are considered beneficial for broader engagement.
• Strong organisational skills combined with project management capabilities enabling you to handle complex regional assignments efficiently.
• Willingness to travel within Southeast Asia (typically 10–25% depending on business needs) to support audits or training initiatives as required.
• Exceptional attention to detail coupled with problem-solving acumen; ability to proactively identify risks while nurturing positive relationships across functions.

What sets this company apart:

This organisation stands out as a trusted leader in healthcare distribution throughout Southeast Asia—renowned for its unwavering commitment to patient safety and product integrity. Employees benefit from an inclusive workplace culture that encourages open communication across all levels while providing ample opportunities for professional growth through structured training programmes. The company’s dedication to continuous improvement means you’ll always have access to new learning experiences—whether through exposure to cutting-edge technologies like electronic QMS platforms or participation in cross-border projects that broaden your perspective. Flexible working arrangements further enhance work-life balance so you can excel professionally without compromising personal wellbeing. By joining this team you become part of a network that values knowledge sharing collaboration mutual respect—and above all—the collective pursuit of excellence in healthcare delivery.

What's next:

If you are ready to take your career in quality assurance to new heights within a supportive regional team environment—this is your moment!

Apply today by clicking on the link provided—your next rewarding challenge awaits.