QRM Lead – Digital Core Implementation

QRM Lead – Digital Core Implementation

Department: Quality Assurance

Summary:

The QRM Lead will establish and embed a risk-based quality management program for a new digitally

enabled biologics manufacturing facility. As the project QRM subject-matter expert, they will ensure that

quality risk management is systematically applied across facility start-up, operational resilience, digital

system dependency, and paperless manufacturing continuity.

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

• Establish and manage the facility QRM program in accordance with applicable regulations, ICH

Q9(R1) and internal procedures.

• Select appropriate risk assessment methods and facilitate the completion, periodic review and

communication of risk assessments.

• Embed risk-based decision-making across facility start-up, manufacturing, automation, data flows

and quality oversight.

• Ensure risk decisions are science-based, documented and inspection-ready.

• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and

assign ownership of risks.

• Develop and maintain the risk management plan for digital and corporate systems, including

DCS, MES, eBR, ERP, data historians and network infrastructure.

• Support project quality and business objectives relating to GxP risk management.

Education and experience:

• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing,

including use of multiple risk assessment methods and facilitation of complex risk assessments.

• Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.

• Demonstrated ability to influence site design, operating models and quality governance.

• Experience managing operational resilience, data integrity and business continuity risks in digital

or paperless environments