Associate Director, Global Quality System & Compliance

The Opportunity:

• Provide strategic and operational leadership to scale and globalize the Quality Management System (QMS), establishing a harmonized, flexible framework that supports international growth and regulatory compliance.

• Lead oversight and expansion of core quality systems across global sites, including document control, GxP training, quality events, supplier management, audits, and batch release.

• Partner with regional teams (including Japan, Europe & other global regions) to integrate local regulatory requirements into the global QMS while maintaining global consistency.

• Establish and govern global quality procedures, including policies, SOPs, and standardized processes to ensure compliance and operational efficiency.

• Ensure inspection readiness and lead support for global health authority inspections, regulatory submissions, and product launches.

• Oversee global quality metrics, compliance monitoring, and management review processes; drive proactive identification, escalation, and mitigation of quality risks.

• Provide governance for electronic quality and validated GxP systems (e.g., Veeva Vault Quality), ensuring they effectively support global operations.

• Collaborate cross-functionally to build and sustain a scalable quality infrastructure aligned with organizational growth and global expansion.

• Champion a culture of continuous improvement and quality excellence across the enterprise.

Required Skills, Experience and Education:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline (advanced degree preferred).

• Minimum of 10+ years of experience in Quality within the pharmaceutical or biotechnology industry, including leadership of global quality systems.

• Demonstrated experience establishing, leading, and maintaining a global Quality Management System (QMS) across multiple regions.

• Proven ability to influence and align senior stakeholders and executive leadership on quality strategy and risk-based decision making.

• Deep knowledge of global GxP regulations and experience ensuring compliance across international markets (e.g., FDA, EMA, PMDA).

• Proven track record supporting global regulatory filings, approvals, inspections, and post-market quality obligations.

Preferred Skills:

• Experience building or transforming global QMS in a growing organization.

• Prior interaction with FDA, EMA, PMDA, and other global health authorities.

• Experience supporting commercial product launches and lifecycle management. 

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