Senior Specialist, Quality Assurance

What you'll do

• Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP.
• Compile lot genealogy and disposition packages to drive timely product release.
• Provide QA oversight for product status, shipping documents, and quality tag-out systems.
• Support and approve deviation investigations, CAPA implementation, and timely closure of quality events.
• Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks).
• Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer).
• Lead and coordinate site projects, investigations, and change controls as needed.

What we're looking for

• Degree or Diploma in Science or Engineering.
• Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
• Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
• Hands-on experience with batch record review, deviation management, and CAPA implementation.
• Proven ability to lead investigations, change controls, and cross-functional projects.
• Effective communication and stakeholder management skills.