GMP Compliance & Lab Operations Specialist

Astellas Pharma; Westborough (MA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

401(k) match

Life Insurance

Annual bonus program

Job summary

Astellas Pharma in Westborough, MA seeks a Compliance and Operations Specialist for the Cytogenomics laboratory in a GMP-regulated environment. You will liaise with Cytogenomics, QA, Validation and vendors to ensure documentation, systems, training, equipment and quality records are compliant and inspection-ready.

Responsibilities include coordinating document control, change management, training compliance, vendor qualification, and audit readiness; supporting regulatory compliance per FDA/EMA

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.

Responsibilities

• Coordinate Document Control and Change Management Activities: Manage the lifecycle of controlled laboratory documents.
• Support Quality Systems and Compliance Records: Coordinate Cytogenomics quality records within TrackWise Digital.
• Maintain Training Compliance and Documentation: Monitor training assignments and ensure qualifications required for GMP activities.
• 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 corrective actions.
• Manage Laboratory Operations Compliance Programs: Coordinate vendor qualification activities, service agreements, maintenance schedules, and laboratory system administration.
• Support Regulatory Compliance: Ensure laboratory activities comply with FDA and EMA guidelines for cell and gene therapy products.

Skills

GMP knowledge

Data integrity

Document control

Change management

Quality systems

Training management

Regulatory compliance

Project coordination

Cross-functional collaboration

Communication skills

Education

BS in Life Sciences or related field

MS in Life Sciences or related field

Tools

TrackWise Digital

Veeva

Job description

Astellas Pharma in Westborough, MA seeks a Compliance and Operations Specialist for the Cytogenomics laboratory in a GMP-regulated environment. You will liaise with Cytogenomics, QA, Validation and vendors to ensure documentation, systems, training, equipment and quality records are compliant and inspection-ready.

Responsibilities include coordinating document control, change management, training compliance, vendor qualification, and audit readiness; supporting regulatory compliance per FDA/EMA