Vice President Operations

Role Overview

The company is a well-established biopharmaceutical business in Asia, supported by recurring revenue, active expansion across regions, and a pipeline that includes both internally developed and licensed products. It is now looking for a Vice President of Operations to drive the next stage of operational maturity and global scale.

This senior leadership position covers the full technical operations value chain, including CMC development, oversight of external manufacturing, supply chain management, and worldwide quality governance. The role is central to building reliable, compliant, and scalable manufacturing capabilities for both existing commercial products and the future pipeline. It also supports global regulatory filings, readiness for clinical supply, dependable commercial supply, and lifecycle execution.

Key Responsibilities

• Shape and direct the CMC strategy from early-stage development through late-stage programs and commercial production.
• Guide process development, technology transfer, scale-up activities, validation work, and product lifecycle management.
• Act as the lead technical point of contact in interactions with regulatory authorities such as the FDA, EMA, and NMPA.
• Lead relationships with CMOs and other external manufacturing partners, including key sites in Italy.
• Oversee GMP execution, batch disposition, deviation handling, and ongoing operational improvements.
• Ensure manufacturing activities consistently meet international safety, quality, compliance, and supply standards.
• Drive process optimization and successful transfer of processes across plants and geographies.
• Head Quality Assurance and Quality Control to maintain complete GMP compliance across operations.
• Build and expand quality systems aligned with expectations in the US, EU, and China.
• Own the strategy and delivery of global clinical and commercial supply chains.
• Design strong systems for forecasting, inventory control, logistics, and cold-chain management where needed.
• Protect supply continuity, improve cost efficiency, and reduce operational risk across regions.
• Contribute at executive level as part of the leadership team, advising on technical risk, investment choices, and overall operational direction.

Requirements

• Advanced qualification in Chemistry, Chemical Engineering, or a closely related discipline; a PhD is preferred.
• At least 20 years of progressively senior experience spanning CMC, drug development, GMP manufacturing, and quality, with strong exposure to small molecule programs.
• Strong background in managing CMOs and external manufacturing networks, ideally with experience in Europe.
• Practical experience in technology transfer, process scale-up, validation, regulatory CMC documentation such as IND, NDA, and MAA, as well as commercial manufacturing.
• Proven success in leading technical teams across multiple countries or regions.
• Good working knowledge of global regulatory frameworks, especially FDA and EMA, with NMPA familiarity preferred.
• Excellent communication and stakeholder engagement skills in multicultural environments.
• Preparedness to travel frequently.

Additional Information

This is a high-impact executive role for a leader who can combine technical depth with strategic oversight, helping the organization scale operations reliably across global markets.