Your mission
The Commercial Quality Assurance Director will be based in Massachusetts and serve as the primary QA contact for commercial operations in the United States, maintaining close alignment with key partners in the United States and Europe. The position requires strategic leadership in developing and expanding a global Quality Management System, as well as extensive knowledge of GMP compliance and regulatory requirements. The Commercial Quality Assurance Director will also manage relationships with external partners, including CMOs, 3PLs, and distributors. The Commercial Quality Assurance Director will also oversee the quality of GMP development partners to ensure seamless integration across the product lifecycle. As we prepare for the launch of pritelivir in 2026, the Commercial Quality Assurance Director will play a critical role in supporting FDA inspection readiness and EMA submission activities while driving quality excellence across global operations.
- Lead the creation, review, and revision of SOPs to ensure commercial readiness and regulatory GMP compliance.
- Shape the evolution of the QMS to meet global commercial and regulatory GMP expectations.
- Implement recall procedures and perform mock recall to ensure recall procedures are adequate.
- Review, negotiate, maintain and manage quality agreements with CMOs, 3PLs, wholesalers and distributors.
- Serve as the primary QA contact for external commercial partners (e.g., CMOs, 3PLs, wholesalers, distributors).
- Develop and deliver training programs on commercial and GMP QA processes across all levels of the organization.
- Provide strategic oversight of GMP compliance across all outsourced manufacturing and packaging activities.
- Act as the QA liaison with internal stakeholders (e.g., Supply Chain, CMC, and Regulatory Affairs) and external service providers.
- Drive vendor qualification, audit strategy, and ongoing performance management.
- Lead / support internal and external audits, as required.
- Ensure inspection readiness for the FDA and support EMA submission activities within your area of responsibility.
- Prepare, review, and/or approve high-impact quality documentation, including batch records, deviations, CAPAs, change controls, product complaints and product quality reviews.
- Support product release processes and ensure timely QA support for supply chain operations.
- Drive continuous improvement initiatives within the commercial/GMP QA framework.