Sr. Quality Systems Engineer

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 Sr. Quality Systems Engineer opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose

The Sr. Quality Systems Engineer role participates in the development and execution of key compliance functions within the larger GMP Quality Assurance department. This position indirectly supports ongoing manufacture of biological clinical trial materials by providing timely and compliant support for quality systems including Change Control administration, Calibration / Validation review, Trackwise system champion and workflow development, inspection management and hosting, internal auditing, supplier management, site Quality Council, quality metrics generation, and site-level compliance deliverables.

Essential Job Responsibilities

• Serves as a lead with the management and administration of the GMP Change Control program. Assists users with navigating the change control decision tree and developing comprehensive change requests. Follows up on action items and assists with change request closure and effectiveness review.
• Performs select technical review as needed, including review of calibration records, executed validation protocols, supplier audit responses and change notices, and other content as appropriate.
• Serves as lead and collaborates cross-functional stakeholders for the generation of quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management, and for review by the Quality Council.
• Supports with internal audit tracking and scheduling. Coordinates scheduling of lead auditors, co-auditors, and auditees. Tracks audit responses and commitments.
• Supports the supplier management program, facilitates Raw Material Risk Assessments for new and changing materials, and helps maintain Supplier Audit schedule. May participate in supplier audits and / or tracking of supplier audit commitments.
• Becomes a resource fluent in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.
• Supplies management with relevant compliance insights; highlights, proposes and implements in continuous improvement opportunities to benefit the department operation and/or the organization at large.
• Performs other duties as assigned or special projects as needed.
  
  

Qualifications

Required:

• BA/BS or equivalent with typically 4 years relevant experience or typically 2 years with Masters degree
• In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of 6 years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering.
• Fluency with most major elements of job description, direct experience with at least one major area
• Fluency in major compliance regulations and consensus standards including 21CFR
• 11,
• 210,
• 211,
• 1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.
• Strong proficiency in MS Word, Excel, PowerPoint, to include basic formulas, and creation / formatting of charts and data tables.
  
  

Preferred

• Experience with an electronic Quality Management System and document management system.
• Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties.
• Experience with supplier and/or internal audits.
• Working knowledge of cell culture manufacturing platforms
• Comfort presenting data, facilitating meetings with senior stakeholders, and maintaining minutes of key decisions and outcomes.
• Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
  
  

Working Environment

• This position is based in Westborough, Ma and will require on-site work.
  
  

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 BioPharma QA

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

EOE including Disability/Protected Veterans