Quality Assurance Manager

Ronald Karchenes

781-***-**** Spring Hill TN *************@*******.*** Ronald Karchenes LinkedInhttps://www.lonepinefarmandstudio.com/

PROFESSIONAL SUMMARY

Experienced Quality Assurance professional with 15+ years in biotech and pharmaceutical industries, leading GMP QA strategy and execution for clinical and commercial product portfolios. Proven expertise in developing and implementing training systems for GMP, GLP, GCP, and CLIA using TrackWise, MasterControl, and Veeva Vault, ensuring compliance and workforce readiness. Serve as QA subject matter expert in supplier qualification, vendor management, risk assessment, SCARs, and audit corrective actions, with experience managing global supplier partnerships. Oversaw receipt and storage of blood samples from Thalassemia patients and reviewed APQRs, PQRs, and stability reports submitted by CMOs for regulatory filings. Demonstrated success in enhancing compliance and operational efficiency through leadership, with in-depth knowledge of ICH guidelines, WHO standards, and regulations including 21 CFR Part 11, Part 210, 211 and EU Annex 11. PICS Guide to Good Manufacturing Practices Part 1 and 2 and the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred. Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems.

Proficient in leading cross-functional teams to drive quality initiatives and inspection readiness across multiple sites. Recognized for fostering strong regulatory relationships and promoting a culture of continuous improvement throughout all levels of the organization.

AREAS OF EXPERTISE

Regulatory Compliance

Product Quality Reviews

Change Controls

Electronic Quality Systems

Audit & Inspection Readiness

Quality Agreements Drafting

SOP Development & Training

Technical Documentation Review

GMP, GLP, GCP, and CLIA Compliance

Analytical Method Qualification

Commercial Portfolio Oversight

Vendor & Supplier Management

Clinical Trial Manager Oversight

Cross Functional Team Leadership

Quality Assurance Strategy Execution

PROFESSIONAL EXPERIENCE

Sanofi, Framingham MA (assignment ended) Nov 2024 – April 2025

Quality Assurance Consultant

Optimized Supplier Change Notification (SCN) processes, improving efficiency, minimizing compliance errors, and reducing approval timelines by 31%.

Authored and updated Product Quality Reviews (PQRs), enhancing regulatory documentation accuracy and readiness.

Built and maintained strong supplier partnerships through the creation and negotiation of comprehensive Quality Assurance Agreements.

BioNTech Manufacturing GmbH, Mainz, Germany (assignment ended) Nov 2023 – Aug 2024

Quality Assurance External Consultant

Developed, updated, and negotiated 6 Quality Assurance agreements with global suppliers across the EU, USA, China, UK, and Singapore, ensuring compliance and alignment with company standards.

Prepared and submitted Product Importation License for clinical trial material in Israel, enabling regulatory-compliant product distribution.

Ultragenyx, Bedford, MA (assignment ended) Aug 2023 – Nov 2023

Senior QA Systems Specialist, Consultant

Transformed over 30 engineering batch records into GMP-compliant documentation, supporting the seamless transition from CMO to in-house manufacturing operations.

Praxis Medicines, Cambridge, MA (position eliminated) Jan 2023 – Mar 2023

Planned and conducted 3 audits of GLP, GCP, and GMP vendors, ensuring compliance with regulatory standards.

Oversaw audit response management and maintained comprehensive vendor records within Veeva Vault, supporting inspection readiness and data integrity.

Editas Medicine Inc., Cambridge, MA Jul 2022 – Jan 2023

Manager, QA Operations

Managed 40 batch record issuance, product disposition, and inspection of patient apheresis, ensuring GMP compliance.

Leveraged Veeva Vault for comprehensive QMS documentation, maintaining accuracy and regulatory readiness.

Directed the receipt, handling, and storage of blood samples from Thalassemia patients, ensuring proper chain of custody and sample integrity.

Agenus Inc., Lexington, MA 2021– 2022

Manager, QA Vendor Management

Directed compliance management for 300+ global vendors, ensuring adherence to GMP, GLP, and GCP standards.

Provided over 70 quality oversight across clinical and commercial pipelines, supporting regulatory compliance and operational excellence.

Facilitated KPI reporting and cross-functional communication, enhancing transparency and process efficiency.

Contributed quality expertise to regulatory submissions including INDs and BLA/MAA for Non-MSI-H cancer programs.

Served as primary QA liaison for outsourced operations, coordinating with Manufacturing, QC, Regulatory, and Supply Chain teams to ensure seamless collaboration.

Supported pre-clinical GLP studies and GCP clinical development, ensuring supplier readiness for PAI and compliance with regulatory expectations.

Quality Assurance Auditor 2016 – 2021

Performed global audits of CMOs, CROs, and clinical sites, ensuring compliance with GMP, GLP, and GCP standards.

Led corporate vendor management across two sites, overseeing performance, compliance, and risk mitigation.

AMAG Pharmaceuticals, Waltham MA 2012– 2016

Sr. Quality Assurance Specialist

Dispositioned commercial and clinical drug products.

Led deviation investigations, CAPAs, and change control reviews.

Managed 5 relationships with CMOs and CROs

Eisai USA, North Andover, MA 2001 - 2010

Acting QA Director, QA Manager, Sr. QA Specialist

Directed QA operations for API manufacturing and GLP/GMP studies, ensuring compliance with global regulatory standards.

Cultivated a strong company-wide quality culture by designing and leading training seminars that connected departmental processes to GxP compliance and customer outcomes.

Supervised and mentored a team of 5 QA professionals, fostering professional growth and operational excellence.

Served on the Eisai International Quality Council, contributing to global quality strategy and decision-making.

Managed corporate inspections and all QMS functions in the pilot plant, ensuring regulatory readiness and compliance.

Built and maintained strong vendor management relationships, enhancing collaboration and quality oversight across the supply chain.

EDUCATION & LEADERSHIP

Bachelor of Liberal Arts with a major in Biology, Boston University, Boston, MA

Eisai President’s Award for Outstanding Performance During Product Launch

Member of Eisai Global Quality Committee

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