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Astellas Pharma Manager, Quality Assurance 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 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 Quality Assurance Training Manager opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. This is an onsite position.

Purpose:

The Manager, Quality Assurance Training role oversees the daily operations of the GMP QA Training team. This position directly supports ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant Training program administration and classroom training.

Essential Job Responsibilities:

  • Manages and grows the QA Training team responsible for administration of the cGMP

  • Training program to include curricula organization and deployment, oversight of organizational training status in both local and enterprise learning management systems (LMS) and providing real-time training consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.

  • Collaborates closely with all department management at the AIRM location to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.

  • Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.

  • Responsible for ensuring training on documentation and training related processes and procedures are performed according to defined expectations.

  • Oversees the QA Training function. Ensures adequate systems are in place to achieve personnel training and qualification compliance with GMP quality expectations.

  • Supplies regular metrics to management with relevant compliance insights, highlights and engages in 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 Senior Manager of Quality Assurance Operations. Directly manages training specialists and collaborates closely with both cross-functional and QA peers.

Required:

  • 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.

  • Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.

  • 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.

  • Background or prior coursework in Cell Biology, basic biological principles, instructional design, and adult learning theory.

  • Experience with MasterControl, TrackWise, Veeva, Plateau, SuccessFactors, or other eQMS / LMS.

  • Working knowledge 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, 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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