Senior Quality Assurance Specialist

Key Responsibilities:

Quality Management System (QMS) Oversight

• Implement, maintain, and continuously improve regional QMS in alignment with global GDP standards and local regulations.
• Ensure CAPA, deviation management, change control processes are effectively managed across the region.
• Coordinate and promptly perform any recall operations for therapeutic/ medical device products
• Ensure that relevant customer complaints are dealt with effectively
• Evaluate on the propose disposition of returned, rejected, recalled or counterfeit products;
• Perform gap analysis and risk assessment, whenever required to support the impact and release of the system/process/product
• Ensure that suppliers and customers are legally approved or authorised to enable lawful supply of TPs and MDs
• Approve any subcontracted activities which may impact on GMP and GDP

Regulatory Compliance & Audits

• Ensure compliance with GDP, GMP, and other applicable regulations in all covered countries.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Coordinate and support external, and regulatory audits; track and follow up on audit findings.
• Assist in analyzing and reporting post-market data to regulatory authorities as required.

Licensing & Certification Support

• Assist with applications, renewals, and maintenance of regulatory licenses (e.g., GDP, ISO13485, GMPMD certificates).
• Act as liaison between local teams and regulatory bodies or health authorities as needed.

Supplier & Third-Party Quality Management

• Conduct or support supplier qualification and audits.
• Monitor quality performance of third-party logistics providers and service vendors.
• Manage and review of Quality & Technical Agreement with supplier & third-party service provider

Training & Capability Building

• Develop and deliver quality-related training to cross-functional teams and local affiliates.
• Ensure that initial and continuous training programmes are implemented and maintained;
• Ensure training compliance and records are up to date.

Quality Metrics & Reporting

• Track, analyse, and report key quality performance indicators (KPIs) across the region.
• Support data-driven decision-making through regular quality reviews and reporting.

Cross-Functional Collaboration

• Partner with local affiliates, supply chain, regulatory affairs, and commercial teams to ensure quality is embedded in operations.
• Act as a regional quality point of contact for global and local initiatives.
• Collaborate with cross-functional teams to develop strategies and solutions to ensure that any additional requirements imposed on certain products by national legislation are adhered to.

Continuous Improvement Initiatives

• Lead or support process improvement projects and harmonization efforts across the region.
• Identify risks and improvement opportunities proactively.
• Document meeting minutes and action items, and track their progress to ensure completion.
• Support submission and operation and in compliance with regional and country-specific guidelines.
• Communication: Effectively communicate regulatory strategy, planning, risks, and suggestions to RA Project Leads, project management, and relevant function colleagues.
• Perform any other ad hoc duties as and when assigned by the Company.

Qualifications:

Education:

• Bachelor's degree (or higher) in Pharmacy, Life Sciences, Chemistry, Biotechnology, Engineering, or a related field.
• Advanced degree (e.g., MSc, MBA) is a plus but not always required.

Experience:

• 5+ years of experience in Quality Assurance, preferably in a regional or multi-country capacity.
• Proven experience with GDP, GMP, and/or ISO 13485 & GDPMD standards.
• Familiarity with regulatory environments across Southeast Asia (e.g., Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Taiwan and Hong Kong) is highly preferred.
• Audit experience (internal, external, supplier) is essential.
• Strong attention to detail, excellent communication skills, and the ability to collaborate effectively with cross-functional teams.

Technical Skills:

• Solid understanding of QMS principles, CAPA, deviation management, change control, and document management.
• Proficiency with audit preparation and response, including knowledge of health authority inspections.
• Knowledge of distribution practices, cold chain (if applicable), and third-party vendor oversight.
• Understand and experience with tools like TrackWise, Veeva, or other electronic QMS platforms.

Soft Skills & Competencies:

• Strong attention to detail, problem-solving, and risk assessment skills.
• Excellent communication and interpersonal abilities, especially for cross-functional collaboration.
• Able to work independently and manage regional complexity.
• Strong organizational and project management skills.

Language & Travel:

• Proficiency in Mandarin and English is required; regional languages are a plus.
• Willingness to travel within the region (typically 10–25%, depending on scope).