Saif Alshagra
Managing Consultant @Oripeutic Bioservices
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WORK HISTORY
Managing Consultant @Oripeutic Bioservices
I lead OriPeutic BioServices, a global consulting firm specializing in biotechnology, pharmaceutical, and medical device industries. We deliver expert solutions in GMP quality systems, regulatory compliance, operational excellence, and technology transfer—helping clients accelerate clinical-to-commercial programs, navigate complex global regulations, and drive innovation in life sciences.With 15+ years of experience across biologics, cell & gene therapy, and medical devices, I partner with clients to: • Design and implement phase-appropriate quality systems (GMP, GDP, GCP, ISO 13485) • Prepare for and support regulatory inspections (FDA, EMA, ICH compliance) • Lead technology transfer and new product introduction (NPI) for advanced therapies • Optimize manufacturing operations and ensure regulatory alignment across CDMOs/CMOs • Develop risk-based CAPA programs, manage deviations, and drive continuous improvement • Support audit readiness, regulatory submissions, and market access strategiesCore Services: • GMP Quality Systems Design & Remediation • Regulatory Strategy & Inspection Readiness • Technology Transfer & NPI Acceleration • ISO 13485 & FDA Compliance Support • CAPA, Deviations, Risk Management Leadership • Lean Six Sigma Process OptimizationMy consulting philosophy is rooted in collaboration, strategic problem-solving, and a commitment to helping life sciences innovators achieve compliance, efficiency, and patient impact.Let’s connect if you’re seeking an experienced consultant to elevate your quality and regulatory outcomes.Learn more: are my entrepreneurial ventures!
EDUCATION
Pepperdine Graziadio Business School
Executive MBA
Oregon State University
Minor in chemistry, Quantitative chemistry
California State University, Northridge
BS, Biotechnology/Medical Technology
California State University, Northridge
Graduate Degree in Business Administration (GCBA Program), Buiness
SKILLS
ABOUT SAIF ALSHAGRA
I’m a Quality & Technical Operations leader who builds inspection-ready organizations and scales them—from first-in-human to commercial launch. Over 15+ years across cell & gene therapy, biologics, and medical devices, I’ve led QMS transformations, BLA-enabling CMC execution, and division-level clinical quality programs that improve outcomes, speed, and compliance.I combine strategy + systems + coaching: translating regulatory intent into simple, durable operating mechanisms (governance, role-based training, analytics, and leader standard work). I’ve delivered measurable results, including –75% deviation backlog, –30% time-to-qualification,>98% training compliance, –25% cleanroom deviations, and accelerated tech transfer/commercial readiness.What I do bestBLA & launch readiness: end-to-end CMC/tech transfer, PPQ readiness, dossier inputs, inspection strategy, and post-approval lifecycle planningTraining at scale: built role-based curricula (Cornerstone super-user), AOQ/APS playbooks, COI/COC controls, and micro-learning that hardwires aseptic excellenceQMS leadership: CAPA/Deviation/Change control, document control, audit programs, Quality Management Review, supplier quality and SCAR performanceClinical quality & patient safety: RCA/FMEA, survey/inspection readiness, performance improvement, dashboards, and cross-functional governance with clinical and operationsLean Six Sigma: DMAIC/A3 to remove waste, compress learning cycles, and raise right-first-time in high-complexity, individualized workflowsRecent work & focusBuilt a cell therapy manufacturing training system (onboarding → qualification → requalification) with simulations and effectiveness checks tied to SOP/Process changesStood up inspection-readiness sprints, SME playbooks, and evidence trails that closed observations and sustained complianceDeveloped a BLA execution playbook (CMC deliverables, PPQ/validation, control strategy, stability, facilities/readiness, post-approval commitments)Harmonized multi-site QMS and analytics (training, CAPA cycle times, complaint/issue trends) to drive executive visibility and faster decisionsI partner well with CEOs, CQOs, Tech Ops, MSAT, QA/RA, and clinical leaders to turn strategy into repeatable results. Open to Executive/Director roles or consulting engagements where speed, compliance, and scale matter—whether that’s BLA filing and launch, division-level clinical quality, or QMS + training modernization.
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