MMK BioPharma Consulting, LLC
Stage-Appropriate Quality Systems
GMP Quality Systems, QC operations, and supplier oversight.
EXPERIENCE THAT SPANS THE BIOPHARMA LIFECYCLE
MMK BioPharma Consulting is led by Mashooma Khalifa, a Quality professional with 14+ years of experience across pharmaceuticals, commercial vaccines, biologics, and cell and gene therapy.
Our practical support connects GMP Quality Systems, QC operations, deviation and CAPA management, OOS/OOT investigations, method validation and transfer, supplier lifecycle management, and CDMO oversight.
We work with emerging biotechnology companies, biologics and cell and gene therapy developers, CDMOs, and life sciences organizations to strengthen processes appropriate to their stage of development.
Consulting Services
Quality Systems Readiness Assessment
A focused review of Quality Systems, deviations, CAPA, documentation and vendor controls, with a prioritized remediation roadmap.
Fractional Quality Systems Support
Defined monthly support for Quality workflows, documentation, investigations and operational priorities.
Supplier Quality & Vendor Oversight
Supplier qualification, vendor lifecycle processes, audit preparation and oversight documentation.
Scope, timelines and fees are agreed in a written proposal. Travel, on-site work and additional deliverables are scoped separately.
Education
2018
Northeastern University
MS Project Management
2012
Salem State University
BS Biology; Chemistry minor
Quality Knowledge & Professional Experience
Practical experience connecting laboratory execution, Quality Systems and cross-functional operations across commercial vaccines, biologics, and cell and gene therapy.
Quality Systems & QC Operations
Deviation and CAPA management; OOS/OOT investigations; change control; SOP development and training; method qualification, validation and transfer; specifications, stability and laboratory workflows.
Supplier Oversight & Operational Improvement
Supplier qualification and lifecycle management, CDMO oversight, audit preparation and support, risk assessment, project coordination, and continuous improvement informed by Lean Six Sigma principles.
Selected Professional Experience
TScan Therapeutics | QC & Quality Systems
Experience spanning cell therapy QC operations and Quality Systems, including vendor lifecycle management, audit support, investigations and cross-functional quality processes.
ElevateBio | QC Leadership & Systems Implementation
Implemented a Veeva Vault Quality OOS module from the ground up: defined workflows, authored SOPs, supported user acceptance testing, trained end users and supported go-live.
Sanofi Pasteur Biologics / Emergent BioSolutions | Commercial Vaccines
QC and materials-testing experience in commercial vaccine manufacturing. Cleared a two-year raw-material testing backlog while keeping current testing on schedule.
These examples describe prior professional experience. Employer names identify that experience and do not imply endorsement of MMK or an MMK client relationship.
Professional Certification
Certified Lean Six Sigma Black Belt
The Council for Six Sigma Certification (CSSC) | Certified October 17, 2026. A foundation for structured problem-solving, process analysis and continuous improvement alongside GMP quality practices.
Why Quality Matters
Quality connects the science behind a product with the controls needed to manufacture and test it consistently. Effective systems help teams make sound decisions throughout development and manufacturing.
Protecting patients through product quality
Manufacturing controls help support the identity, strength, quality and purity of medicines. Quality must be built into operations; final-product testing alone cannot replace well-controlled processes.
Making data dependable
Clear records, appropriate methods and reliable laboratory practices help teams understand results, investigate problems and make traceable decisions.
Learning from issues
Deviation investigations and corrective and preventive actions help teams understand causes, address weaknesses and check whether improvements work.
Building readiness as programs grow
Defined responsibilities, training, supplier oversight and change control help organizations manage complexity as development and manufacturing activities evolve. Stage-appropriate implementation must still meet applicable requirements.
Improving how work gets done
Consistent workflows and structured problem-solving can reduce avoidable rework and support more predictable operations. Lean Six Sigma complements GMP controls; it does not replace them.
Learn more: FDA: Facts About Current Good Manufacturing Practice. Educational content is general; project recommendations depend on the product, activities and applicable requirements.
Resources & Innovation
Quality Systems Lab (QSL) — Practical Quality Systems education, tools and templates for professionals building stronger everyday quality practices. Follow @qualitysystemslab on Instagram.
Veridion — Coming soon
Regulatory intelligence software in development, designed to help teams explore inspection findings and compliance trends.
Request a Consultation
Tell us about your organization, Quality priorities and timeline. Email: mkhalifa@mmk-bpc.com