Compliance and Operations Specialist
Astellas Pharma
Summary
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.
Job description
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.
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 and support closure of quality records.
- Maintain Training Compliance and Documentation: Monitor and coordinate training assignments, curricula, and documentation; perform routine reviews of training records 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; assist with internal audits and quality assessments by compiling documentation and tracking commitments.
- Manage Laboratory Operations Compliance Programs: Coordinate vendor qualification activities, service agreements, preventative maintenance schedules, and laboratory system administration activities.
- Support Regulatory Compliance: Ensure laboratory activities comply with relevant regulatory requirements, including FDA and EMA guidelines for cell and gene therapy products.
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.
Requirements
- BS with 8+ years or MS with 4+ years of experience in Life Sciences, Biotechnology, Biological Sciences, Quality Systems, or a related field
- 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
- Experience managing controlled documentation including SOPs, forms, document revisions, periodic reviews, and document change control
- 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
- Strong organizational and project coordination skills
- Excellent written and verbal communication skills
- 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
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 401(k) Matching
- Company Paid Life Insurance
- Annual Corporate Bonus
- Quarterly Sales Incentive
- Long Term Incentive Plan
- Company Fleet Vehicle
- Referral Bonus Program
Company overview
Astellas Pharma Inc. is a leading Japanese multinational pharmaceutical company headquartered in Tokyo, Japan. Founded in April 2005 through the merger of Yamanouchi Pharmaceutical (established 1923) and Fujisawa Pharmaceutical (established 1894), Astellas has grown into a global life sciences company with operations in more than 70 countries worldwide. The company employs approximately 14,500 people globally and generates annual revenues exceeding $12 billion. Astellas is committed to turning innovative science into value for patients through transformative therapies in key therapeutic areas including oncology, ophthalmology, urology, immunology, and women's health. The company's notable products include Xtandi for prostate cancer, Padcev for bladder cancer, Xospata for acute myeloid leukemia, Veozah for menopausal symptoms, and Izervay for geographic atrophy. With a strong focus on research and development, Astellas invests approximately 17% of its sales revenue into pioneering new healthcare solutions for diseases with high unmet medical needs. The company operates multiple research centers in Japan, the United States, and Europe, and has established strategic partnerships and acquisitions to expand its pipeline and capabilities in areas such as gene therapy and immuno-oncology.