AiCuris Anti-infective Cures AG
Commercial Quality Assurance Director*
AiCuris Anti-infective Cures AG, Waltham, Massachusetts, United States, 02254
4 days ago Be among the first 25 applicants
Responsibilities
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
Bachelor'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.
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 other's 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Business Consulting and Services
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Responsibilities
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
Bachelor'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.
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 other's 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Business Consulting and Services
#J-18808-Ljbffr