Astellas Pharma · 1 month ago
Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness
Westborough, MA, 01580, United States
Full-time
Onsite
Mid LevelAstellas Pharma is a global pharmaceutical company committed to developing innovative therapies. The Quality Systems Engineer will manage the internal audit program to ensure compliance with Good Manufacturing Practices and support quality system improvements.
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
Experience in managing and maintaining internal audit programs in a cGMP environment
Strong understanding of current Good Manufacturing Practices (cGMP), company policies, and global regulatory standards
Ability to identify compliance risks and support quality system improvements
Experience in conducting internal audits across GMP-regulated areas
Strong documentation skills for preparing inspection checklists, audit reports, and metrics
Excellent communication skills to convey audit results and trends to stakeholders
Experience in developing and tracking Corrective & Preventative Action (CAPA) plans
Ability to prepare and maintain audit-related metrics and dashboards
Experience in supporting inspection readiness plans and training
Participation in continuous improvement initiatives within Quality Assurance
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
Founded in 2005
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
Company data provided by crunchbase