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Astellas Pharma Senior Manager, Quality Assurance 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 Senior Manager, Quality Assurance opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA . This is an onsite position. Purpose and Scope: The Senior Manager, Quality Assurance role oversees the daily operations of the GMP QA Operations, Document Control, and Training teams. This position directly supports ongoing manufacture of biological clinical trial materials by providing timely and compliant batch and material review, batch disposition, Document Control, and Training.

Essential Job Responsibilities:

  • Manages and grows the QA Operations team responsible for batch review, batch disposition, manufacturing / QC process support, and raw material disposition.

  • Provides real-time compliance consultation to cross-functional stakeholders at antiseptic cell culture manufacturing facility.

  • Assists with, reviews, and may approve completed investigations in area of responsibility.

  • Ensures relevant CAPA are appropriate and effective.

  • Participates in strategic initiatives related to new projects and programs, helps develop the QA support strategies to help advance Astellas’ strategic engagements.

  • Facilitates oversight for CMO support activities.

  • Serves as a resource fluent in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.

  • Oversees the QA Operations, Document Control, and Training functions through subordinate.

  • Ensures adequate systems are in place to achieve compliance with industry expectations for GMP documents and data integrity.

  • Supplies regular metrics to management with relevant compliance insights; highlights and engages continuous improvement opportunities.

  • Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.

Quantitative Dimensions:

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.

Organizational Context:

Reports to the Director of Quality Assurance, and supervises subordinate managers overseeing QA Operations, Document Control, and Training functions. Collaborates with peers whose teams focus on Deviation, CAPA, Quality Systems, and Validation work.

Qualifications:

Required

  • BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 10+ years or MS with 8+ years related experience in bio-pharma industry, and 4+ years of managerial experience in a cGMP compliance environment.

  • Thorough fluency in batch record review, batch disposition, GMP production oversight, and a demonstrated track record of leadership and management of Quality / Compliance personnel.

  • Fluency in GMP training, document administration, and data integrity principles.

  • 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.

Preferred

  • Experience participating in, preparing for and/or hosting external regulatory audits.

  • Working knowledge of adult learning theory and organizational training techniques.

  • Experience with MasterControl, TrackWise, Veeva, or other eQMS.

  • Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.

  • Background or previous coursework in Cell Biology and basic biological principles.

  • Experience supervising and coaching subordinate leaders to achieve organizational results.

Benefits:

  • 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

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Category Development QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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