QA Specialist

RXILIENT MEDICAL PTE. LTD.; Glasgow; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading healthcare organization is seeking a Quality Assurance Manager based in Glasgow to oversee quality systems in compliance with global regulations. The role involves managing audits, regulatory interactions, and training initiatives while ensuring adherence to quality standards across the region.

Qualifications

• 5+ years of experience in Quality Assurance in a regional capacity.
• Familiarity with GDP, GMP, ISO 13485 standards.
• Strong organizational and project management skills.

Responsibilities

• Oversee regional quality management systems (QMS) and compliance.
• Coordinate audits and ensure corrective actions are implemented.
• Develop and deliver quality-related training.

Skills

Quality Management System (QMS)

Regulatory Compliance

Attention to Detail

Communication

Problem Solving

Project Management

Education

Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Engineering

Advanced degree (e.g., MSc, MBA)

Tools

TrackWise

Veeva

Job description

Tasks & Responsibilities

Key Activities

• Quality Management System (QMS) Oversight
• Implement, maintain, and continuously improve regional QMS in alignment with global GDP standards and local regulations.
• Ensure documentation, CAPA, deviation management, change control processes are effectively managed across the region.
• Coordinate and promptly perform any recall operations for therapeutic products
• Ensure that relevant customer complaints are dealt with effectively
• Ensure that suppliers and customers are legally approved or authorised to enable lawful supply of TPs
• Approve any subcontracted activities which may impact on 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 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.
• Decide on the final disposition of returned, rejected, recalled or counterfeit products;
• Approve any returns to saleable stock;

• 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 / REQUIREMENTS

Knowledge/

Experience

• 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, or ISO 13485 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.

Work Skills

• 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.
• Comfortable 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).