Commercial Quality Assurance Director
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- Bachelors masters 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.
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.
*AiCuris is an employer that supports equal opportunities diversity and inclusion. We welcome applications from people regardless of their national origin skin color religion gender age marital status disability sexual orientation gender identity or other legally protected characteristics.
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
About Company
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 can ... View more
