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.

About the role

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.

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.

Required Qualifications

• BS with 8+, MS with 4+ years of experience in Life Sciences, Biotechnology, Biological Sciences, Quality Systems, or a related field; equivalent experience may be considered.
• Minimum 3–5 years of experience in a regulated laboratory, pharmaceutical, biotechnology, or quality systems environment.
• Working knowledge of GMP requirements, data integrity principles, and quality system processes applicable to regulated laboratory operations.
• Experience managing controlled documentation, including SOPs, forms, document revisions, periodic reviews, and document change control processes.
• Experience supporting quality records such as change controls, deviations/nonconformances, investigations, CAPAs, and effectiveness checks within an electronic quality management system.
• Knowledge of training management processes and experience maintaining training records, curricula, qualification documentation, and compliance metrics.
• Experience supporting laboratory instrumentation or computerized systems, including qualification, maintenance, calibration, access management, or lifecycle documentation activities.
• Strong organizational and project coordination skills with the ability to manage multiple priorities, track deliverables, and ensure timely completion of compliance-related activities.
• Excellent written and verbal communication skills with demonstrated ability to collaborate effectively across Quality Assurance, Validation, laboratory operations, vendors, and other cross-functional stakeholders.

Preferred Qualifications

• Experience with TrackWise Digital (TWD), Veeva, or similar quality management systems.
• Experience in a GMP analytical, QC, Cytogenomics, or molecular biology laboratory.
• Experience preparing for regulatory inspections and internal/external audits.
• Knowledge of computerized system validation (CSV) and laboratory instrument qualification processes.

Location and Working Environment

This position is based in Westborough, MA and will require primarily on-site work in a laboratory and office working environment.

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 fleet vehicle for eligible positions
• Referral bonus program

Pay

$94,570 – $135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)