Quality Assurance - Biotechnology CDMO
Quality Assurance professionals in a biotech CDMO ensure that products and processes meet regulatory and company standards throughout the R&D and manufacturing lifecycle. Their purpose is to protect patient safety and product efficacy by embedding quality systems into development activities and by verifying compliance with FDA/EMA regulations.
6 leveled profiles. Pick a level to see the full profile.
Individual contributor
Perform routine QA tasks under close supervision, assist in executing internal audits and in-process checks, conduct basic investigations of minor deviations, and support training sessions.
Review and approve SOPs, conduct and document internal audits, lead investigations for moderate deviations, and provide training and guidance to P1 staff.
Oversee daily QA oversight for a project or department, coordinate complex audits, lead CAPA teams, and serve as QA point-of-contact for cross-functional teams.
Manage a QA team or function, approve critical quality documents, drive quality initiatives, and liaise with regulatory bodies during audits.
Develop and implement QA policies, oversee all QA activities, lead major interactions with regulators, and allocate budget and resources for quality programs.
Set the vision for global QA strategy, provide executive leadership, advise C-suite on regulatory strategy, and drive innovation in quality management.