Regional QA Manager

3 weeks ago

Singapore SCIGEN PTE. LTD. Full time
Roles & Responsibilities

As the regional Quality Assurance Manager, the incumbent is responsible for overseeing all aspects of Quality Assurance (“QA”) within the Group. The incumbent serves as the key point of contact on all QA matters to all stakeholders, both internally and externally such as third-party manufacturers. The ideal candidate will have a strong background in QA methodologies, excellent leadership skills, and the ability to drive continuous improvement in QA processes and practices, in the commercial QA and QA of third-party manufacturing scopes.


Key Roles and Responsibilities:


Management Representative as part of GDP for Marketing Distributor

· Conduct due diligence reviews of in-licensed products for quality and regulatory compliance.

· Review, establishment and management of QA agreements with distributors and Third-Party Manufacturers.

· Develop and implement QA strategies, policies, and procedures to ensure product quality compliance.

· Establish and maintain metrics and key performance indicators (KPIs) to measure and monitor QA performance and identify areas for improvement.

· Create, update and maintain the QA SOPs and Quality Management System for compliance.

· Conduct regular internal / external audits and reviews of QA processes and practices on SciGen and vendors to identify areas for improvement and implement CAPA as needed.


QA liaison-in-charge with Third-Party Manufacturers (TPM)

· Ensure product manufactured by TPMs meet quality standards and Regulatory Affairs compliance.

· Maintain oversight by monitoring TPMs operations and facilitate issue resolution.

· Drive improvements in quality, efficacy and product quality through effective communication with TPMs.

· Attend to and coordinate external audits from health authorities and support QA-related audits for the manufacturing sites as required in the region.


Responsible Person (RP) of Singapore Importer & Wholesaler Licence

· Ensure quality and compliance of commercialised pharmaceutical products throughout their lifecycle.

· Manage secondary packaging site in Singapore and secondary packaging process.

· Review and approve commercial batches for release to the market.

· Monitor and liaise with manufacturers and distributors on product complaints, temperature excursions, quarterly reconciliations, etc.

· Conduct and / or approve validation of transport and storage processes and systems, including temperature controls and management.

· Manage change control and deviation processes with impact assessment.

· Handle product complaints and recalls, with investigations and implement CAPA.

· Perform vendor management, evaluation and oversight of suppliers.

· Conduct similar duties with other markets outside of Singapore and share best practices with the local team members.


In-house QA Subject Matter Expert and Advocator

· Conduct QA training for both internal and external stakeholders, while providing guidance, recommendation and support to internal stakeholders as needed.

· Collaborate with cross-functional teams, including but not limited to Regulatory Affairs, Supply Chain, Commercial and Business Development to drive alignment on quality goals and priorities.

· Keep abreast on industry best practices, trends, and technologies related to QA, and recommend and implement improvements to QA methodologies and tools.

Foster a culture of quality and continuous improvement within SciGen as a Group, championing QA best practices and driving accountability for quality across all teams.



Requirements:

· Degree in Life Sciences or equivalent.

· At least 5-10 years of proven track record in QA management with good exposure of Third-Party Manufacturing and compliance QA in the pharmaceutical and / or medical devices industry.

· In-depth understanding of GMP / GDP / GxP principles and regulation requirements.

· Strong knowledge of QA methodologies, tools, and processes.

· Proficient in planning and conducting inspections and audits; Lead Auditor certification highly preferred.

· Strong technical report review and writing skills.

· Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and influence without authority.

· Strong analytical and problem-solving skills, with the ability to identify root causes of quality issues and implement effective solutions.

· Versatile and adaptable to changes in multiple priorities and requirements while meeting scheduled milestones.


Tell employers what skills you have

GxP
Quality Assurance Plan
Pharmaceutical Industry
Strategic Planning
CAPA
External Audit
Pharmaceutical Manufacturing
Change Management
Quality Assurance
Quality Improvement
Interpersonal Skills
Good Manufacturing Practices
GMP
Investigation
Project Management
Medical Devices
Internal Audit Quality Assurance
Change Control
QMS, Quality Management Systems
Life Sciences

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