Commercial Quality Assurance Director*

Your missionThe 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.Your profileBachelor's, master's, or doctoral degree in a relevant scientific discipline (e.g., biology, chemistry, or pharmacy).Minimum 7 years of experience in biotech/pharma with exposure to commercial products.Deep understanding of FDA regulations (21 CFR Parts 210/211 and 600) and EU GMP (EudraLex, Volume 4) and global commercial quality standards.Proven experience in building and scaling QMS for commercial operations.Ideally, experience with computerized system validation in a GxP-regulated environment.Strong strategic thinking, communication, and stakeholder management skills.Detail-oriented with strong analytical and problem-solving abilities.Experience working in global regulatory environments and managing international QA operations is a plus.Ability to travel occasionally for audits, inspections, and team meetings.Close collaboration and alignment with the global QA team in Germany.Fluency in English.Why us?Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.Development: We encourage people to grow and strongly support individual development and learning opportunities.Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.Benefits: Competitive comprehensive benefit plan. #J-18808-Ljbffr