Senior Quality Assurance Specialist Lead - Cell & Gene Therapy
A highly experienced Quality Assurance Lead with over 10 years in the pharmaceutical and biologics industry, specializing in GMP compliance and regulatory readiness for sterile manufacturing. Proven expertise in leading quality programs, directing CAPA and risk management (FMEA/RCA), and supervising batch release for complex products including cell & gene therapies and combination products. Adept ...
Experience: 10+ years
Muhammad Saleem provides regulatory consulting services to clients in:
Possesses a strong clinical and scientific foundation with a Doctor of Pharmacy (Pharm-D), complemented by advanced certifications in Six Sigma (Green and Black Belt) from the University of Massachusetts Boston. This unique combination of pharmaceutical science and quality process improvement methodologies provides a robust framework for navigating complex regulatory challenges in the medtech industry. This educational background is particularly valuable for companies developing combination products or requiring rigorous quality management systems.
Contributes to the broader scientific community through publications on topics such as transdermal drug delivery systems and clinical disease management. This work demonstrates a commitment to advancing pharmaceutical science and showcases the ability to research and articulate complex technical subjects. Such contributions underscore a deep-seated expertise that is beneficial for clients needing well-researched and documented regulatory strategies.
Demonstrates over a decade of progressive leadership in quality assurance within the pharmaceutical and biologics sectors, holding senior roles at major companies like Amneal and Pfizer. This professional has a proven track record of leading GMP compliance programs for sterile manufacturing, including cutting-edge cell and gene therapies. Key achievements include directing comprehensive CAPA and risk management activities, overseeing CMOs, and ensuring regulatory readiness for FDA and EMA inspections. Their experience extends to providing crucial quality support for pharmaceutical medical devices, including sterilization validation and CAPA for device-related processes, making them a highly valuable asset for medtech organizations.
A highly experienced Quality Assurance Lead with over 10 years in the pharmaceutical and biologics industry, specializing in GMP compliance and regulatory readiness for sterile manufacturing. Proven expertise in leading quality programs, directing CAPA and risk management (FMEA/RCA), and supervising...
With over 10 years of specialized experience in the pharmaceutical and biologics sectors, Muhammad Saleem offers medtech companies profound expertise in Quality Assurance for complex and highly regulated products. His deep knowledge of GMP compliance, sterile manufacturing, and risk management (FMEA/RCA) is critical for organizations developing combination products, cell & gene therapies, or sterile medical devices. Having led quality programs and managed successful FDA/EMA interactions at major firms like Pfizer, he provides a proven framework for establishing robust Quality Management Systems. His expertise in sterilization validation, CAPA direction, and post-market support makes him an invaluable asset for ensuring audit readiness and maintaining the highest standards of product quality and regulatory compliance.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
Share a brief overview of your device and timeline. Cruxi will forward your request to Muhammad Saleem and help structure next steps.
Contact Now