QA Digital Manufacturing Lead

Job Title: QA Digital Manufacturing Lead (Review by Exception & eBR)

Department: QA

Summary

The QA Digital Manufacturing Lead provides Quality Assurance oversight and guidance for the implementation of digital manufacturing solutions within a pharma manufacturing environment. The role focuses on enabling review by exception (RBE), electronic batch records (eBR), and paperless operations, ensuring compliance with GMP, data integrity, and regulatory expectations while supporting operational efficiency.

Responsibilities

• Provide QA leadership and guidance for the design and implementation of eBR and paperless manufacturing processes.
• Define and approve review by exception (RBE) strategies, including deviation thresholds, exception handling, and QA review models.
• Ensure digital manufacturing solutions are aligned with GMP, data integrity principles (ALCOA+), and applicable regulatory requirements (e.g., FDA, EU).
• Partner with Manufacturing, Automation, IT, and Quality teams to embed quality by design into digital workflows.
• Review and approve quality requirements, risk assessments, and validation/CSA deliverables related todigital plant systems.
• Support inspection readiness by ensuring digital processes are defensible, well governed, and clearly documented.

Education and Experience

• Strong QA background in pharmaceutical manufacturing under GMP.
• Hands on experience with eBR, DeltaV, MES, or digital manufacturing systems.
• Solid understanding of review by exception concepts and paperless batch release.
• Ability to balance compliance, risk based thinking, and operational efficiency