Head of Quality, with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing (sterile and non-sterile) experience with over 17 years industry practice. Overall background and specialties include GMP & GLP, which has led to strategic management of major programs such as gap analysis and transformation of Product Quality Systems (PQS), SOP transformation and optimization, QMS frameworks, and operational systems audits. She is passionate about continuous improvement activities and consistently building quality into each area of the life sciences. Advocate & Committee Member for the Tourette’s Association of America and Powershift Ambassador for Daymond John.

Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25+ years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working knowledge of GCP/GLP frameworks for FDA/EU regulations and guidelines. Experienced in Deviation/CAPA Management, Change Management, SOP development, Vendor Oversight and Quality Auditing, Regulatory Inspection Readiness, QMS development and implementation, Training, CMC documentation review and product disposition. Other areas of experience include Product Complaint investigations, APR/PQR, Quality metrics compilation and reporting.

With 26 years of experience in the pharmaceutical industry since 2000, Renata brings expertise across Quality Control Microbiology, Quality Systems, and Regulatory Affairs, supporting R&D and Commercial manufacturing, including sterile and non-sterile operations. Renata focuses on strengthening quality systems, compliance, and inspection readiness, with experience in GLP/GMP, QMS, Deviations, CAPA, Change Control, Complaint Management, CSV, audits, and risk management. Renata also develops and delivers trainings and thought leadership, guiding teams through major and critical quality events with a focus on sustainable corrective and preventive actions.

Brendan is a Manager, Document Control & Training at Mersana Therapeutics, with over 15 years of biopharma industry experience in development landscapes ranging from preclinical to commercial organizations. Overall background includes roles ranging from manufacturing operator on the floor to Quality-focused roles in Compliance, Document Control, and Training, specializing in Veeva systems and training administration. He is particularly passionate about Inspection-Readiness, Continuous Improvement, and implementing electronic solutions. Brendan enjoys the outdoors and extensive hiking in his native state of New Hampshire.