Senior GMP Compliance & Quality Assurance Lead

Astellas; Westborough (MA); On-site; USD 83,000 - 118,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Paid Time Off (Vacation and Sick) and

401(k) match

Annual Corporate Bonus

Long Term Incentive Plan

Company fleet vehicle

Job summary

Astellas Westborough, MA is seeking a Senior Compliance Specialist to lead QA compliance activities across GMP manufacturing programs as the company advances through clinical trials and commercialization.

The role collaborates with Manufacturing, Quality Control, Materials Management and contract manufacturers to ensure alignment with cGMPs, drive CAPA and continuous improvement, and mentor junior staff in regulatory requirements.

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 5+ years QA experience in GMP industry (or 3+ years with MSc)
• Strong knowledge of cGMP regulations for biotechnology, cell therapy, or gene therapy, including ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
• Experience in Deviation investigations, root cause analysis, and CAPA effectiveness verification
• Proficiency in the use of the Microsoft Office Suite (Excel, PowerPoint, Word)
• Ability to interpret regulatory rules, guidance, and industry standards to make objective, risk-based decisions and communicate these effectively to internal stakeholders
• Strong written and verbal communication skills for report generation and presenting compliance findings to senior leadership

Responsibilities

• QA Compliance Oversight: Independently performs QA reviews of Manufacturing batch records, QC test records, raw material inspection records, and calibration records, identifying and addressing documentation errors and deviations from SOPs or specifications.
• Deviation and CAPA Support: Leads deviation investigations, identifies root causes, and manages corrective and preventive actions (CAPA). Assists in more complex investigations and ensures compliance records are thorough, technically sound, and risk-based.
• Internal Audits and Self-Inspections: Acts as a lead participant in the GMP Self-Inspection program, collaborating with teams across the organization to ensure adherence to both domestic and international GMP regulations and Astellas procedures.
• Contract Manufacturing Oversight: Assist in the oversight of contract manufacturing organizations (CMOs), reviewing compliance-related documents, ensuring alignment with company standards, and following up on compliance issues or concerns.
• Process Improvement: Identifies, recommends, and helps implement improvements to quality processes and procedures, aiming to improve overall operational efficiency and compliance.
• Mentorship and Collaboration: Serves as a resource for less experienced compliance staff, providing mentorship on compliance-related tasks and helping troubleshoot complex quality issues.
• SOP Development: Leads the development and revision of standard operating procedures (SOPs) and other quality documents to address new compliance requirements and improve existing practices.
• Metrics and Reporting: Aggregates, analyzes, and presents monthly compliance metrics. Collaborates with senior compliance specialists and management to drive continuous improvement initiatives based on findings.
• Continuous Compliance Improvement: Actively participates in continuous improvement initiatives by identifying areas of inefficiency or potential compliance risks and proposing solutions.
• Cross-functional Collaboration: Works closely with cross-functional teams such as Manufacturing, QC, and Materials Management to ensure alignment on compliance activities and to help identify and mitigate compliance risks.

Skills

GMP knowledge

Deviation investigations

Root cause analysis

Regulatory interpretation

Communication skills

MS Office

Education

BS/BA in Life Sciences, Engineering, or Chemistry

Tools

MS Office

Job description

Astellas Westborough, MA is seeking a Senior Compliance Specialist to lead QA compliance activities across GMP manufacturing programs as the company advances through clinical trials and commercialization.

The role collaborates with Manufacturing, Quality Control, Materials Management and contract manufacturers to ensure alignment with cGMPs, drive CAPA and continuous improvement, and mentor junior staff in regulatory requirements.