QA Digital Manufacturing Lead
Summary
The QA Digital Manufacturing Lead provides Quality Assurance leadership for the implementation of digital manufacturing solutions, including electronic batch records and review by exception processes. The role ensures compliance with GMP requirements while supporting efficient, paperless manufacturing operations.
Responsibilities
Provide QA oversight and guidance for the design, implementation, and maintenance of electronic batch record (eBR) and paperless manufacturing processes.Define, review, and approve Review by Exception (RBE) strategies, including exception handling processes, deviation thresholds, and QA review models.Ensure digital manufacturing solutions comply with GMP requirements, data integrity expectations, and applicable regulatory standards.Collaborate with Manufacturing, Automation, IT, and Quality teams to integrate qua...