Sr. Quality Systems Engineer

Astellas Pharma • Westborough, MA

393d

About The Position

The Sr. Quality Systems Engineer at Astellas Institute for Regenerative Medicine (AIRM) plays a crucial role in ensuring compliance within the GMP Quality Assurance department. This position supports the manufacture of biological clinical trial materials by managing quality systems, including Change Control, Calibration/Validation review, and internal auditing, while also providing insights for continuous improvement.

Requirements

• BA/BS or equivalent with typically 4+ years relevant experience or 2+ years with a Master's degree.
• In lieu of a Life Sciences degree, a minimum of 6+ years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering is acceptable.
• Fluency with major compliance regulations including 21CFR §11, §210, §211, §1271; EudraLex Volume IV; ICH Q9, Q10.
• Ability to interpret regulatory rules and make objective, risk-based decisions.
• Strong proficiency in MS Word, Excel, and PowerPoint.

Nice To Haves

• Experience with an electronic Quality Management System and document management system.
• Solid written and oral communication skills for interdepartmental collaboration.
• Experience with supplier and/or internal audits.
• Working knowledge of cell culture manufacturing platforms.
• Comfort presenting data and facilitating meetings with senior stakeholders.

Responsibilities

• Manage and administer the GMP Change Control program, assisting users with change requests and follow-up on action items.
• Perform technical reviews of calibration records, validation protocols, and supplier audit responses.
• Collaborate with stakeholders to generate quality-facing monthly metrics for management and Quality Council review.
• Coordinate internal audit scheduling and track audit responses and commitments.
• Facilitate Raw Material Risk Assessments and maintain Supplier Audit schedules, participating in audits as needed.
• Provide consultation on quality considerations related to aseptic biotechnology manufacturing.
• Identify and implement continuous improvement opportunities within the department.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options including Vacation, Sick time, and national holidays
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree