Lead Compliance Specialist
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Lead Compliance Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The Lead Compliance Specialist will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.
Essential Job Responsibilities:
Essential Duties and Responsibilities include, but are not limited to, the following:
Individual Contributor responsible for QA Compliance Strategy for clinical and pre-commercial cell and gene therapies. Serves as QA lead for clinical programs and initiatives related to new projects at AIRM. Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. Serves as a resource fluent in GMP Self-Inspection / Internal Audits for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations. Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items. Develops compliant Quality processes and procedures to satisfy new compliance requirements and leads improvement of existing work practices. Aggregates and presents monthly metrics, identifying, planning, and executing continuous improvement opportunities for process efficiencies and compliance improvements to benefit department operations and / or the organization at large.