Compliance and Operations Specialist

Compliance and Operations Specialist

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Compliance and Operations Specialist is responsible for supporting the quality, compliance, and operational readiness of the Cytogenomics laboratory within a GMP-regulated environment. This role serves as a key liaison between Cytogenomics, Quality Assurance, Validation, and external vendors to ensure laboratory documentation, systems, training, equipment, and quality records are maintained in a state of compliance and inspection readiness.

The position provides administrative and technical support for document control, change management, investigations, training compliance, laboratory system administration, equipment lifecycle management, vendor qualification, and audit preparedness activities. Through proactive oversight of quality systems and laboratory processes, this role helps ensure adherence to regulatory requirements, internal procedures, and data integrity standards while enabling efficient laboratory operations.

Role and Responsibilities

• Coordinate Document Control and Change Management Activities: Manage the lifecycle of controlled laboratory documents. Support document change controls and ensure documentation remains compliant with GMP and data integrity requirements.
• Support Quality Systems and Compliance Records: Serve as a coordinator for Cytogenomics quality records within TrackWise Digital (TWD. Facilitate timely completion of actions, maintain compliance with established procedures, and support closure of quality records.
• Maintain Training Compliance and Documentation: Monitor and coordinate training assignments, curricula, and documentation to ensure personnel maintain qualifications required for GMP activities. Perform routine reviews of training records, support audit readiness, and assist with remediation of training compliance gaps.
• Partner with Quality Assurance and Validation Functions: Coordinate activities required to maintain GMP-compliant laboratory instrumentation and computerized systems throughout their lifecycle.
• Support Inspection and Audit Readiness: Maintain records and compliance metrics that demonstrate inspection readiness. Assist with internal audits and quality assessments by compiling documentation, tracking commitments, and supporting implementation of corrective actions.
• Manage Laboratory Operations Compliance Programs: Coordinate vendor qualification activities, service agreements, preventative maintenance schedules, and laboratory system administration activities. Partner with laboratory staff to ensure continuous adherence to GMP requirements.
• Support Regulatory Compliance: Ensure laboratory activities comply with relevant regulatory requirements, including FDA and EMA guidelines for cell and gene therapy products.