Mark Connor
About Mark Connor
Mark Connor is a QA Lead at Bristol-Myers Squibb with extensive experience in quality systems management and regulatory guidance.
Professional Title and Current Role
Mark Connor holds the position of QA Lead at Bristol-Myers Squibb. In his role, he is responsible for ensuring the quality and safety of biopharmaceutical products. His duties include overseeing batch-related documentation, participating in audits, and assessing and approving deviations and Corrective and Preventive Actions (CAPAs).
Career at Sanofi Genzyme
Mark Connor worked at Sanofi Genzyme for 13 years, from 2005 to 2018. During his tenure in Allston, MA, he served as a QA professional. His responsibilities included performing reviews and approvals of batch-related documentation and ensuring compliance with regulatory standards. He also participated in audits and was involved in scale-up implementation projects.
Previous Role at Abbott Labs
From 2001 to 2004, Mark Connor worked at Abbott Labs as a Lab Manager. Over his three-year stint, he gained valuable experience in lab management and quality systems. His role involved managing lab operations, which provided him with a solid foundation in quality management and regulatory compliance.
Quality Systems Management and Regulatory Guidance
Mark Connor has extensive experience in Quality Systems management. He provides regulatory guidance and training, contributing to maintaining high standards in product development and manufacturing. His role also likely involves implementing and overseeing Risk Evaluation and Mitigation Strategies (REMS) to ensure patient safety. Additionally, he engages in continuous improvement processes to enhance product quality and compliance with regulatory standards.
Skills and Expertise in Audits and Compliance
Mark Connor is skilled in performing reviews and approvals of batch-related documentation and disposition. He participates in audits and has the ability to assess and approve deviations and CAPAs. His experience includes working with consent decrees, ensuring compliance with stringent regulatory requirements, and maintaining high standards in the biopharmaceutical industry.