Quality Assurance Manager Life Sciences

About SIMABS

SIMABS is a forward-thinking biotechnology venture dedicated to delivering cost-effective therapeutic monoclonal antibodies to the biopharmaceutical industry. With a focus on simplicity, innovation, and a vibrant start-up culture, we are setting new standards in biopharmaceutical manufacturing. If you're ready to lead a quality team and drive strategic excellence in our industry, SIMABS is the perfect place for you!

Your Role

As our QA Manager, you will lead and oversee our entire quality assurance function. You will be responsible for managing both strategic and operational QA activities, ensuring the highest quality standards across our processes. You will work closely with senior management and the Head of Quality, driving continuous improvement and ensuring compliance with GMP and GDP standards.

Key Responsibilities:

Leadership & Strategy

• Team Management: Lead, mentor, and develop a high-performing QA team.


• Strategic Oversight: Develop and implement quality strategies aligned with the company’s growth objectives.


• Cross-Functional Collaboration: Work with senior management to integrate quality best practices across all departments.

Project Quality Assurance

• Product Implementation: Oversee the implementation of new products at our GMP site.


• Technical Reviews: Guide the review and discussion of tech transfer data packages and implementation documents.


• Validation: Supervise the preparation and review of project-specific validation protocols and reports.

Routine Quality Assurance

• Documentation: Ensure the accuracy and completeness of master batch records and batch record reviews.


• Environmental Monitoring: Oversee environmental monitoring activities.


• Material Management: Ensure quality release of incoming materials and robust material specifications.


• Supplier Oversight: Direct supplier qualification and requalification processes.


• Compliance: Enforce strict adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Quality Management System (QMS) Maintenance

• Monitoring: Supervise monitoring and follow-up on events, deviations, supplier complaints, OOS, CAPA, and change requests.


• Documentation Management: Oversee the writing and review of SOPs, work instructions, and forms; ensure proper archiving of records.


• Continuous Improvement: Collaborate closely with the Head of Quality to enhance our quality processes and systems.