QA Digital Manufacturing Lead

Quality Risk Management Lead– Digital Core implementation

Department: QA

 

The QRM lead is responsible for redefining and embedding a risk-based quality management approach for a new, digitally enabled biologics manufacturing facility. The role ensures that quality risk management is systematically applied across processes, systems, and operations, with particular focus on operational resiliency, digital system dependency, and paperless manufacturing continuity.

 

Essential Duties and Responsibilities include, but are not limited to, the following:

• Design and implement a modern, facility-wide Quality Risk Management (QRM) framework, aligned with ICH Q9(R1), supporting a fully digital plant.
• Embed risk-based thinking into all aspects of facility startup, including manufacturing processes, digital
• systems, automation, data flows, and quality oversight.
• Assess and manage risks related to dependency on digital and corporate systems, including DCS, MES, eBR, ERP, data historians, and network infrastructure.
• Define and govern business continuity and contingency strategies to ensure GMP compliance during system outages (e.g., network failures, cloud unavailability), including controlled fallback for paperless operations.
• Partner with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are proactively identified, mitigated, and owned.
• Ensure risk decisions are science-based, documented, and inspection-ready, supporting regulatory confidence in a highly digital operating model.

Education and experience:

• Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing.
• Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.
• Proven ability to operate at a strategic level, influencing site design, operating models, and quality governance.
• Experience addressing operational resiliency, data integrity, and business continuity in digital or paperless environments.