Industries

Pharmaceutical

Biotechnology

Pharmaceuticals

Blood / Plasma for further manufacturing

Nutraceuticals

Vaccines

Antigens / Antibodies

Clinical Trials

Nutraceutical

Manufacturing

CLIA Laboratory

Analytical Laboratory

Environments

• Multi-Site Operations: Providing unified QA oversight for distributed facilities, such as blood centers, clinical trial sites, or manufacturing networks, with standardized CAPA, audits, and training
• Consent Decree and Regulatory Enforcement Scenarios: Leading remediation in high-stakes environments under FDA/EMA decrees, rebuilding systems, labs, and cultures to achieve resolution
• Startup and Early-Stage Ventures: Building foundational QMS for emerging biotech and regenerative medicine companies, ensuring compliance from inception and accelerating path to FDA licensure or accreditation
• Growth and Expansion Phases: Scaling quality systems during rapid expansion, including multi-site integrations, process optimizations, and eQMS implementations to support increased operations
• Continuous Improvement and Efficiency Drives: Applying Lean/Six Sigma and KPI metrics to enhance lab and manufacturing processes, reducing deviations and timelines in ongoing operations
• Business Model Transformation: Guiding strategic shifts, such as transitioning to ISO standards, adopting digital tools, or reorienting from traditional pharma to biologics, while maintaining compliance and quality culture
• Supplier and Vendor Management Networks: Conducting risk-based audits and ensuring supply chain compliance in complex, multi-vendor ecosystems
• High-Volume Testing and Lab Environments: Optimizing workflows in CLIA-certified labs or national testing facilities, including LIMS implementations and OOS investigations for efficiency and accuracy
• Audit-Intensive and Inspection-Ready Settings: Preparing for and hosting frequent regulatory audits, reducing risks and improving notification processes in blood services or pharma manufacturing

At QMS Assurance Solutions LLC, our mission is to empower pharmaceutical and biotechnology organizations to achieve unwavering compliance and operational excellence through tailored Quality Management Systems (QMS) remediation and enhancement. Founded by Jonathon Rochelle, a seasoned Quality Assurance Executive with over 25 years of hands-on leadership in GxP compliance, Consent Decree remediation, and global quality system transformations, we bridge the gap between regulatory demands and business success. Drawing from proven expertise in hosting 40+ FDA audits, implementing eQMS platforms like TrackWise and MasterControl, and authoring the insightful book QMS Remediation in Pharma: A Practical Guide to Restoring Compliance and Building Resilient Quality Systems, we deliver practical, risk-based solutions that not only resolve deficiencies but also foster a culture of quality, driving efficiency and innovation in clinical trials, manufacturing, and beyond.
What sets us apart is our deep-rooted commitment to proactive, client-centric strategies that go beyond mere compliance to create resilient, future-proof systems. Unlike generic consultants, we leverage Jonathon’s extensive track record—spanning Lean/Six Sigma initiatives, KPI-driven performance improvements, and cross-functional team mentoring across ISO 9001, CLIA, and AABB environments—to customize approaches that reduce deviations, streamline processes, and enhance stakeholder trust. By partnering with us, clients gain a strategic ally who transforms quality challenges into competitive advantages, ensuring seamless operations, minimized risks, and sustained regulatory success in an ever-evolving industry.