Quality Risk Management Lead

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Summary:

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.

Requirements

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.