Senior Quality Assurance Manager

About the Company

Seeking an experienced and entrepreneurial Senior Manager, Quality Assurance to establish and lead the company's regional Quality function across Southeast Asia. This is a unique opportunity to join a high-growth biopharmaceutical organization and play a pivotal role in building the quality and patient safety infrastructure that will support the successful commercialization of innovative therapies across the region.

About the Role

You will be responsible for developing and managing the regional Quality Management System (QMS), ensuring compliance across the end-to-end supply chain, and overseeing quality operations involving licensors, manufacturing partners, distributors, warehouses, and logistics providers. In addition, this role will assume responsibility for establishing foundational Pharmacovigilance (PV) framework, including safety reporting processes, adverse event management pathways, partner oversight, and compliance governance until a dedicated PV function is established. This is a highly visible and strategic position that combines operational excellence with the opportunity to build new capabilities within a dynamic biotech startup environment.

Responsibilities

• Quality Management & Compliance
• Regulatory & Inspection Readiness
• Product Quality & Pharmacovigilance Oversight
• Cross-Functional Partnership

Qualifications

• Minimum 8 years of Quality Assurance experience within the pharmaceutical, biotechnology, or life sciences industry.
• Strong experience supporting biologics, specialty medicines, or innovative therapies.

Deep expertise in:

• GMP and GDP compliance
• Quality Management Systems
• Quality Agreements
• CAPA and deviation management
• Change control
• Product complaint handling
• Recall management
• Quality risk management
• Proven experience operating within regional Southeast Asia or APAC distribution and regulatory environments.
• Knowledge of local GDP licensing requirements and Health Authority expectations, particularly within Southeast Asia.
• Practical exposure to Pharmacovigilance, safety reporting, PV vendors, distributor oversight, or local safety compliance requirements.
• Experience supporting pre-launch activities, Early Access Programs, or Named Patient Programs is advantageous.

Required Skills

• Strong leadership and stakeholder management capabilities with the ability to influence both internal and external partners.
• Proven success managing third-party quality providers, contract manufacturers, logistics partners, distributors, and service vendors.
• Comfortable operating in a fast-paced startup environment with the ability to create structure, processes, and governance frameworks from the ground up.
• Highly autonomous with strong problem-solving skills, sound judgement, and a hands-on approach.
• Resilient, adaptable, and capable of balancing strategic priorities with operational execution.