Astellas Pharma - Westborough, MA
posted 3 months ago
The Quality Assurance Site Leader (Senior Director) at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA, plays a pivotal role in ensuring the quality and compliance of pharmaceutical products. This position is designed for a strategic leader who will oversee all aspects of Good Manufacturing Practice (GMP) and non-GMP Quality Assurance (QA) activities. The Site Leader will collaborate closely with the site management team and will be responsible for supervising a team of QA managers and specialists. The primary goal is to ensure that all operations comply with regulatory requirements, Astellas Quality standards, and local site policies and procedures. In this role, the Site Leader will develop and implement quality strategies that align with both short- and long-term objectives for the QA organization. This includes ensuring compliance with established standard operating procedures (SOPs) and preparing for regulatory authority inspections. The Site Leader will also foster a culture of quality and compliance within the organization, encouraging independent thinking and strong relationships across various functions. The position requires a proactive approach to quality improvements, with responsibilities that include evaluating trends and risks, optimizing QA processes, and acting as the primary interface with Regulatory Authorities. The Site Leader will also be involved in mentoring and developing QA professionals, ensuring that the team is equipped to meet the challenges of the pharmaceutical industry. This role is critical in maintaining the integrity of Astellas' commitment to delivering innovative therapies to patients.