Commercial Quality Assurance Director

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.

Your profile

Why us

About us

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product PREVYMIS marketed by our partner MSD treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people an otherwise manageable infection can mean life or death. AiCuris with its expertise and growing pipeline is committed to providing therapeutic solutions for them now and in the future.

We believe in a culture of trust and transparency where feedback is considered an opportunity to contribute to each others personal and professional growth. We hire people who are collaborative adaptable communicate well and love to learn.

Required Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1