Quality Assurance Manager

Are you passionate about biologics and quality excellence?Do you thrive in a role where you lead critical quality operations for cutting-edge biologic products?Are you ready to influence compliance and drive collaboration across global teams?If your answer is yes, we have an exciting opportunity for you!Our client partner is seeking a Drug Substance (DS) Lead – Biologics with extensive experience in monoclonal antibody products.Overall Purpose:As the DS Lead, Biologics, you will ensure compliance for externally manufactured biological products. You’ll play a pivotal role in supporting Qualified Persons (QPs) on commercial operations, ensuring timely product release, and maintaining robust local quality systems. This position is key to guaranteeing that activities at Contract Manufacturing Organizations (CMOs) meet regulatory expectations and align with quality agreements.What You’ll Do:Lead quality interactions with DS CMOs and oversee DS projects.Review and approve Master Batch Records and PCS before new manufacturing campaigns.Ensure executed batch documentation meets GMP and marketing authorization requirements.Manage deviations, change controls, CAPAs, and complaints by liaising with CMOs and internal stakeholders.Organize periodic quality meetings to track and close quality actions.Support technology transfers and validation activities from a quality perspective.Prepare annual product reviews (APR/PQR) for biologics.Maintain product specifications and associated documentation for batch release.Track and communicate CMO change notifications in line with quality agreements.Apply risk management tools to drive compliance and continuous improvement.Support QA IT systems and global standards implementation.Ensure inspection readiness for audits by partners and regulatory authorities.What We’re Looking For:Experience: 8–10 years in the biotechnology industry, preferably with monoclonal antibody products.Skills: Strong interpersonal, negotiation, and influencing abilities.Ability to manage teams and complex priorities effectively.Collaborative mindset with a passion for cross-cultural teamwork.People-oriented, proactive, and willing to go beyond your core responsibilities.Why Join Us?You’ll be part of a dynamic environment where your expertise shapes the future of biologics quality. This role offers the chance to lead, innovate, and make a tangible impact on global healthcare.Ready to take the next step?Apply now and help us deliver biologics with uncompromising quality!