Astellas Pharma · 1 day ago
Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness
Westborough, MA
Full-time
Hybrid
Mid, Senior Level
$80K/yr - $125K/yr
5+ years expAstellas Pharma is a global pharmaceutical company focused on developing innovative therapies for patients. The Quality Systems Engineer will manage the internal audit program to ensure compliance with cGMP and support quality system improvements while maintaining inspection readiness for regulatory audits.
BiotechnologyHealth CareMedical
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
Qualification
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
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
Company-paid fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
2025-12-18
Company data provided by crunchbase