Sandra Minera
About Sandra Minera
Sandra Minera is the Director of External Commercial QA at Alkermes and the Senior Director of External Manufacturing Quality North America at Bausch Health Companies Inc.
Current Roles and Responsibilities
Sandra Minera currently holds two significant positions in the pharmaceutical industry. She works as the Senior Director of External Manufacturing Quality North America at Bausch Health Companies Inc. in New Jersey, where she is responsible for overseeing quality systems across various external manufacturing sites. Additionally, she serves as the Director of External Commercial QA at Alkermes in Wilmington, Ohio, where she focuses on quality assurance for commercial products. These roles demonstrate her expertise in maintaining rigorous quality standards in complex manufacturing environments.
Professional Experience
Sandra Minera has amassed extensive experience in quality assurance and compliance throughout her career. Before her current roles, she worked at Alkermes in multiple capacities: Associate Director of Quality Assurance Operations, Quality Compliance Manager, and QA Compliance Manager spanning from 2009 to 2016. Prior to her tenure at Alkermes, she served as the QA Sterile Fill Finish Manager at Elan Pharmaceuticals and as the Quality Assurance Supervisor at Wyeth BioPharma. Her career began at Schering Plough, where she worked as a Microbiology Senior Analyst. Her roles have equipped her with multifaceted skills in operational quality systems and compliance.
Educational Background
Sandra Minera holds a Master's degree in Pharmaceutical Manufacturing Technology from Trinity College Dublin, completed in 2008. She also earned a Bachelor's degree in Industrial Microbiology and Chemistry from University College Dublin in 2000. Her educational background has laid a strong foundation for her comprehensive understanding of pharmaceutical manufacturing and quality assurance processes.
Expertise in Quality Systems
Sandra Minera has demonstrated considerable expertise in the establishment, maintenance, and continuous improvement of Quality Systems within pharmaceutical manufacturing environments. Her experience includes in-depth knowledge of validation requirements and the associated documentation review processes. She has been instrumental in implementing and refining quality systems to ensure compliance with industry regulations and standards.
Operational Excellence Initiatives
Throughout her career, Sandra Minera has participated in various Operational Excellence activities aimed at improving efficiencies and eliminating waste within manufacturing processes. Her initiatives have contributed to the streamlined operations and enhanced quality management in the organizations she has worked with. Her role in cross-functional teams has further highlighted her leadership skills and ability to drive process improvements across different operational areas.