Astellas Pharma Manager, Quality Systems 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 Manager, Quality Systems opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA . This is an onsite position.
Purpose and Scope
The Manager, Quality Systems role oversees the daily operations of the Quality Systems team within the larger Quality Assurance organization. This position and the supporting team directly support ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant risk management, change management, supplier management, and Quality governance support.
Essential Job Responsibilities:
Manages and grows the QA Quality Systems team responsible for Change Control, Supplier
Management, Quality Council, Risk Management, Quality Manual, and Self Inspection.
Provides real-time compliance consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility. Plays a key role in hosting regulatory inspections.
Manages the Change Control program for processes, facilities, equipment, and software.
Manages or collaborates to manage the Supplier Management system, assessing new materials and suppliers for compliance risk and acceptability.
Serves as a resource fluent in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.
Oversees the QA Quality Systems function. Ensures adequate systems are in place to achieve compliance with GMP quality system expectations for ATMP cell therapy products and cell banks.
Manages or collaborates to manage the Quality Council / Quality Management Review program to regularly provide the organization with relevant compliance insights and to highlight continuous improvement opportunities.
Provides coaching, mentoring, professional development, and performance management to junior Quality Systems staff as appropriate.
This position will regularly operate in a time-sensitive environment, with direct impact on the ability to sustain key manufacturing activities and provide value to patients in need.
Reports to the Senior Manager of Quality Assurance responsible for Quality Systems and Validation. Collaborates closely with cross-functional stakeholders and QA peers who focus on batch disposition, Deviation, CAPA, and compliance investigation work.
BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
Thorough fluency in GMP Change Management, Supplier Management, and GMP auditing principles.
Fluency in Quality Risk Management principles and their implementation.
Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
Advanced proficiency in MS Word, Excel, and PowerPoint
Experience participating in, preparing for and/or hosting external regulatory audits.
Background or prior coursework in Cell Biology and basic biological principles.
Experience with the MasterControl, TrackWise, Veeva, or other eQMS.
Experience with Contract Manufacturing Organization (CMO) oversight and compliance.
Working knowledge of MS Visio and MS Project.
Experience supervising and coaching subordinate leaders to achieve organizational results.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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