- Company Name
- BioLyo Technologies BV
- Job Title
- Senior Quality Assurance Specialist
- Job Description
-
**Job Title**
Senior Quality Assurance Specialist
**Role Summary**
Lead QA strategy and execution for a biotech organization’s GMP processes, overseeing both internal and outsourced manufacturing. Acts as subject‑matter expert, ensuring all activities meet regulatory standards, contributing to audits, validations, and continuous improvement of the QMS.
**Expectations**
- Deliver high‑quality oversight for late‑stage clinical and commercial biopharmaceutical manufacturing.
- Maintain compliance with cGMP (EudraLex Vol. 4, 21 CFR, ICH/WHO) across in‑house and CDMO partners.
- Drive QMS advancements, audit readiness, and risk management.
**Key Responsibilities**
- Collaborate with QA/QP, QC, CMC, and Process Development leads to refine the QMS.
- Define and execute PAI readiness plans for QC labs and contracted CDMOs, steering toward commercial manufacturing licensing.
- Contribute to management review meetings; provide data‑driven insights.
- Lead the internal audit program, validating eQMS implementation and computer‑integrated data integrity.
- Perform risk assessments for processes and quality, and implement mitigation strategies.
- Audit CDMO facilities, assess QMS readiness, and qualify them as drug substance, product, and cell bank vendors.
- Oversee day‑to‑day QA review of manufacturing activities, deviations, change controls, CAPA, and OOX documentation.
- Review and approve tech‑transfer documents, master batch records, specifications, and other critical records.
- Conduct root‑cause analyses of batch issues, and communicate risks to stakeholders.
**Required Skills**
- Strong leadership and knowledge‑sharing across cross‑functional teams.
- Expertise in GMP regulatory frameworks (EudraLex, 21 CFR, ICH/WHO, USP/EP).
- Proven experience with eQMS implementation, data integrity, and OX‑validation.
- Proficiency in audit planning, execution, and vendor qualification.
- Ability to conduct PPQ and support BLA filings from QA perspective.
- Excellent written and verbal communication in English; additional language skills valued.
- Strong analytical, problem‑solving, and project‑management capabilities.
**Required Education & Certifications**
- Master’s degree or equivalent in pharmaceutical science, bioengineering, biomedical sciences, or related field.
- 10–15 years of QA experience in a GMP environment (pharma or biotech), including late‑stage clinical and commercial manufacturing.
- Minimum 5 years of QA experience overseeing outsourced manufacturing of biologics.
- Demonstrated participation in on‑site US FDA or equivalent health‑authority inspections.
- Certifications in GMP/QA, eQMS, or risk‑management (e.g., ASQ CQE, Six Sigma) are advantageous.