Quality Risk Management Lead
Confirmed on the employer's own hiring board on Oct 31, 2026. First seen by Alion on Oct 7, 2026.
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.