Director, Commercial Product Quality

Director, Commercial Product Quality

This senior leadership role sits at the heart of ensuring the highest standards of quality, compliance, and operational excellence across commercial pharmaceutical manufacturing activities. You will oversee end-to-end product quality spanning intermediates, APIs, drug product, packaging, labeling, and distribution within a highly regulated global environment. Acting as a key quality authority, you will shape and strengthen quality systems while supporting the international commercialization of innovative oncology and rare disease therapies. The role combines strategic leadership with hands-on expertise, requiring close collaboration across manufacturing, regulatory, and cross-functional teams worldwide. You will play a critical part in ensuring patient safety, regulatory alignment, and continuous improvement across global operations. This is an opportunity to influence quality strategy at scale within a fast-growing, mission-driven life sciences organization.

Accountabilities

• Lead and evolve global pharmaceutical quality systems across commercial manufacturing, ensuring compliance with GMP, ICH guidelines, and international regulatory standards (including FDA and EMA expectations).
• Oversee quality assurance and control across intermediates, API, drug product, packaging, labeling, and commercial distribution, ensuring consistent product quality and regulatory readiness.
• Drive continuous improvement initiatives across pharmaceutical quality systems, embedding best practices and strengthening cross-site alignment and performance.
• Act as a strategic partner to manufacturing and cross-functional teams to integrate quality requirements early in product development and lifecycle management.
• Establish robust analytical frameworks for quality issue resolution, ensuring structured problem-solving and capability development within the team.
• Lead regulatory compliance strategy and ensure inspection readiness across all relevant operations and partner networks.
• Ensure documentation and record-keeping systems meet global regulatory expectations and are effectively managed across internal and external stakeholders.

Requirements

You bring extensive experience in pharmaceutical or biotechnology quality leadership, with a strong track record in regulated manufacturing environments. You are confident operating at both strategic and operational levels, combining deep technical expertise with strong leadership and influencing skills. You have led teams and quality functions in complex, global organizations and are comfortable navigating regulatory frameworks and cross-functional collaboration.

• 12+ years of experience in Quality within pharmaceutical or biotechnology industries, including 8+ years in leadership roles.
• Strong expertise in GMP, ICH guidelines, and global regulatory requirements (FDA, EMA, and other health authorities).
• Proven experience in pharmaceutical quality systems, including QA/QC, manufacturing compliance, and continuous improvement programs.
• Demonstrated ability to lead teams and drive quality strategy across multiple sites or global operations.
• Strong stakeholder management and communication skills, with the ability to influence across technical and executive levels.
• Experience implementing and improving quality systems in highly regulated environments.
• Strong analytical mindset with a focus on structured problem-solving and measurable outcomes.
• Bachelor's degree in a scientific or engineering discipline required; advanced degree preferred.

Benefits

• Competitive salary with annual performance-based bonus
• Equity-based incentive program
• Hybrid and remote work flexibility depending on location
• Generous vacation and paid wellness days
• Learning and professional development support
• Global, mission-driven work environment in the life sciences sector
• Inclusive and diverse international team culture
• Opportunity to contribute to impactful therapies in oncology and rare diseases