Job Description
Are you ready to shape the future of medicine? Aetheria Biopharma is seeking a precision-driven Senior QA Specialist to join our innovative team in the heart of the Cambridge biotech hub. You will play a pivotal role in ensuring our groundbreaking therapies meet the highest global regulatory standards, driving patient safety and excellence in clinical development.
We offer a dynamic, high-growth environment where your expertise in cGMP compliance directly impacts the success of life-saving pharmaceutical products.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in alignment with FDA and EMA regulations.
- Conduct rigorous internal and external audits to ensure supply chain and manufacturing compliance.
- Manage the CAPA process, performing root cause analysis for deviations and non-conformance incidents.
- Review and approve batch records, validation protocols, and technical reports for pharmaceutical release.
- Collaborate cross-functionally with R&D and Manufacturing teams to implement quality-by-design (QbD) principles.
- Provide expert guidance on cGMP training and regulatory inspection readiness programs.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related Life Science field.
- Minimum 5+ years of experience in Pharmaceutical Quality Assurance or Quality Control.
- Deep understanding of 21 CFR Part 210/211 and ICH Q7 guidelines.
- Proven ability to manage complex investigations and technical documentation.
- Strong analytical mindset with excellent communication skills for stakeholder management.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is highly preferred.