Astellas Pharma Supervisor, QA Document Control and Training in Westborough, Massachusetts
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 of 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 Supervisor, QA Document Control and Training opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.
The Supervisor of Document Control and Training will be responsible for supervising the maintenance and administration of the Astellas Institute for Regenerative Medicine (AIRM) GMP document control and training systems.
Essential Job Responsibilities:
Coordinates the GMP document control and training systems, ensuring compliance with Regulatory, AIRM Quality, and Astellas corporate requirements.
Leads and performs QA document control functions, including document tracking, formatting, biennial review, processing, issuance/reconciliation, maintenance of controlled book copies/locations, and obsoletion/archiving of documents.
Owns the cross-functional collaboration process, providing guidance on the generation and revision of procedures and works with department management to ensure timely completion of document change requests per evolving business needs.
Ensures accuracy of GMP documentation (reviewing for completeness, accurate authorization, and impact to other Quality systems) and that accurate filing is maintained.
Identifies and execute continuous improvement initiatives to improve the current document control and training systems.
Investigates deviations against the document control and training systems and develops effective CAPA plans.
Manages and performs training functions, including working with department management (Facilities, QC Analytical, QC Microbiology, Manufacturing, Quality Assurance, and Regulatory) to develop and maintain role‑based curricula and to build vital training content for processes/procedures and verification of Classroom and OJT Training Tasks in the LMS.
Collaborates with department management to define Classroom‑based and On-the-Job (OJT) training by procedure (as applicable) in a harmonized and appropriate training approach.
Ensures training on related processes and procedures are performed according to defined expectations.
Supports audits (internal, external) in order to verify that Regulatory and Quality requirements have been met.
Aggregates monthly documentation and training compliance related metrics for management review.
Consistently achieves individual goals as set out in Star Performance
Consistently completes work effectively and efficiently
Reports to Next Line Manager
This position has direct line management responsibilities
BS with 6+ or MS with 4+ years laboratory experience, or equivalent
Quality professional with hands-on experience with document management and training in a regulated industry -- pharmaceutical, biologics, or medical device -- with direct document control management and LMS administration experience.
Familiar with FDA regulations, including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance
Sophisticated proficiency with MS Word
Familiarity with GMP Training concepts and requirements. Prior experience with curricula design, training content creation, and delivery.
Previous experience with the MasterControl electronic quality management system strongly preferred
Working understanding of adult learning theory, effective training formats
Proficiency with electronic training module creation software (Storyline, Captivate, Lectora, etc.)
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Quality Assurance/Quality Control
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans