Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness

Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness

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 health 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 Systems Engineer- Self Inspection & Audit/Inspection Readiness opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Quality System Engineer, Self-Inspection & Audit/Inspection Readiness, is responsible for managing and maintaining the site’s internal audit (self-inspection) program to ensure continuous compliance with current Good Manufacturing Practices (cGMP), company policies, and global regulatory standards. This role plays a vital part in proactively identifying site compliance risks, supporting quality system improvements, and maintaining a constant state of inspection readiness for external health authority audits.

The successful candidate will promote data integrity, quality, and compliance across a broad range of Quality Assurance (QA) activities and collaborate closely with cross-functional teams at Astellas Regenerative Institute of Medicine (AIRM) to ensure consistent delivery of high-quality products to patients.

Essential Job Responsibilities:

• Audit program administration: Develop, implement, and maintain the annual self-inspection master schedule/matrix to plan, conduct, and track audits or inspections across departments, processes, and quality systems.
• Audit Execution: Lead/co-lead, participate and support internal audits across all GMP-regulated areas, including manufacturing processes/cleanrooms, quality control, materials management, facilities, engineering, etc.
• Documentation & Reporting: Prepare and maintain inspection checklists and questionnaires. Accurately document audit observations and findings using a risk-based classification system (e.g., critical, major, minor). Draft and issue formal audit reports summarizing results and recommendations.
• Communication and Follow-up: Communicate audit results to stakeholders, identify trends, and support follow-up activities to ensure timely completion of action items.
• Corrective & Preventative Action (CAPA): Collaborate with auditees and department representatives to develop effective CAPA plans for addressing identified deficiencies. Track progress, ensure timely completion, and assist with effectiveness verification activities.
• Metrics & Reporting: Prepare and maintain monthly audit-related metrics and dashboards for review by Quality Assurance and site management during Quality Council or Management Review meetings.
• Inspection Readiness: Support the development and maintain the site’s inspection readiness plan, including managing checklists, tracking action items, and supporting readiness training. Act as audit host (inspection administrator) or support representative during corporate, regulatory, or third-party audits.
• Continuous Improvement: Participate in continuous improvement initiatives to identify efficiencies and enhance compliance and operational excellence across QA and related departments.
• Additional Duties: Perform other quality-related duties and participate in ad hoc projects as assigned.

Qualifications:

Qualifications Required:

• BA/BS or equivalent with typically 5 years relevant experience or typically 3 years with master’s degree
• In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of 6 years of relevant experience in biotechnology and/or pharmaceutical Quality Assurance or Quality Engineering.
• Strong proficiency in MS Word, Excel, PowerPoint, to include basic formulas, and creation / formatting of charts and data tables.
• Demonstrated knowledge of core GMP quality system functions, with hands-on experience in at least one key area.
• Comfortable presenting data, facilitating discussions, and maintaining accurate documentation of decisions and actions.
• Familiarity with an electronic Quality Management System (i.e. Trackwise, Veeva, etc.)
• Fluency in major compliance regulations and consensus standards including 21CFR §11, §210, §211, §1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc.

Preferred:

• Experience developing and managing self-inspection or internal audit programs.
• Experience providing GMP or quality systems training to peers or cross-functional staff.
• Exposure to corporate or regulatory audits, including preparation and audit support activities.
• Experience in an environment subject to regulatory audits, i.e., interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
• Experience with quality systems such as Change Control, Deviations/Non-Conformances, and CAPA, including root cause analysis and risk assessment.
• Experience with supplier audits is a plus
• Working knowledge of cell culture manufacturing processes desirable

Working Environment:

• This position is based in Westborough, Ma and will require on-site work. Hybrid work from certain locations/situations may be permitted in accordance with Astellas’ responsible Flexibility Guidelines.

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

#LI-TD