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Astellas Pharma Sr. 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 Sr. Manager, Quality Assurance opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Senior Manager, Quality Assurance role is responsible for 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, deviation and CAPA management, Document Control, and Training.

Essential Job Responsibilities:

  • Leads and grows the QA Operations team responsible for batch review, batch disposition, manufacturing / QC process support, raw material disposition, and the Deviation and CAPA programs. Provides real-time compliance consultation to cross-functional partners at an aseptic cell culture manufacturing facility.

  • Assists with, reviews, and/or approves completed investigations. Ensures CAPAs are appropriate and effective.

  • Participates in critical 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 proficient in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.

  • Coordinates the QA Document Control and Training programs through subordinate managers. 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.

  • Builds and manages the GMP Self-Inspection / Internal Audit program for AIRM.

  • 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.

Organizational Context:

  • Reports to the Director of Quality Assurance, and supervisors subordinate managers coordinating QA Operations, Document Control, and Training functions

Qualifications:

Required:

  • BA/BS or equivalent with typically 8+ years proven experience or typically 6+ years with Master's degree

  • Detailed proficiency in Deviation investigation techniques, root cause analysis methods, CAPA efficiency verification, and product impact assessments.

  • Solid understanding 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.

  • Sophisticated proficiency in MS Word, Excel, and Powerpoint.

Preferred:

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

  • Solid understanding of adult learning theory and organizational training techniques.

  • Experience with the MasterControl electronic quality management system.

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

  • Solid understanding of MS Visio and MS Project.

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

Benefits:

  • 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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Category Quality Assurance/Quality Control

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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