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 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.
Essential Duties and Responsibilities include, but are not limited to, the following:
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Provide QA leadership and guidance for the design and implementation of eBR and paperless manufacturing processes.
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Define and approve review by exception (RBE) strategies, including deviation thresholds, exception handling, and QA review models.
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Ensure digital manufacturing solutions are aligned with GMP, data integrity principles (ALCOA+), and applicable regulatory requirements (e.g., FDA, EU).
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Partner with Manufacturing, Automation, IT, and Quality teams to embed quality-by-design into digital workflows.
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Review and approve quality requirements, risk assessments, and validation/CSA deliverables related to digital plant systems.
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Support inspection readiness by ensuring digital processes are defensible, well-governed, and clearly documented.
Education and Experience:
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Strong QA background in pharmaceutical manufacturing under GMP.
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Hands-on experience with eBR, DeltaV, MES, or digital manufacturing systems.
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Solid understanding of review by exception concepts and paperless batch release.
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Ability to balance compliance, risk-based thinking, and operational efficiency.
