Quality Assurance Manager

Biolojic Design, Ltd. is a leading-edge company specializing in the design of therapeutic multi-specific human antibodies, using AI and machine learning approaches. We are currently seeking a talented and experienced Quality Assurance Manager to join our team.

Responsibilities:

·        Establish QA Processes: Evaluate existing R&D procedures, set goals; and develop a detailed quality implementation plan.

·        Maintain QA Systems: Establish and maintain QA systems and processes and implement a robust eQMS tailored to the company’s specific needs.

·        Develop SOPs: Identify critical processes requiring SOPs, develop these SOPs, and ensure their implementation and training on the SOPs. Ensure SOPs are maintained with the propre lifecycle maintenance including annual reviews, updates and retirement processes.

·        Prepare and execute internal audits based on defined SOPs

·        Regulatory Compliance: Ensure all processes and lab activities comply with relevant regulatory standards. Prepare for and manage regulatory inspections and audits.

·        Implement CAPAs: Address non-conformances through corrective and preventive actions (CAPAs) and manage the investigation and resolution of product quality issues.

·        Documentation: Ensure accurate and timely documentation of all QA and R&D activities to support traceability and accountability.

·        Training Programs: Develop comprehensive training programs for all employees on QA principles, SOPs, and regulatory requirements, and conduct training sessions.

·        Supplier and Vendor Audits: Qualify and audit suppliers and vendors to ensure they meet the company’s quality standards.

Required Experience and Skills:

·        Strong knowledge of regulatory requirements and quality standards (GxP e.g., GDocP, GMP, GLP).

·        Experience in establishing and managing QA processes in a biotech or pharmaceutical environment, especially at the research stage.

·        Background in life sciences and/or chemistry.

·        Experience with electronic QMS (Familiarity with Almond is a plus).

·        Strong communication and interpersonal skills to effectively implement new processes, train staff, and liaise with regulatory bodies.

For applications, please send your CV to [email protected]

More about us: https://www.Biolojic.com/