Senior Compliance Specialist

Purpose & Scope

The Senior Compliance Specialist will perform advanced QA compliance tasks and provide oversight in support of GMP manufacturing programs as AIRM progresses through clinical trials and commercialization. This role will act as a key player in maintaining compliance across a variety of Quality Assurance areas and will work collaboratively with cross-functional teams (Manufacturing, Quality Control, Materials Management) to ensure high standards of quality and patient value delivery. The successful candidate will demonstrate increasing independence in compliance-related decision-making, while also supporting the leadership team on more complex compliance initiatives.

Role and 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. Tracks key compliance metrics and provides periodic updates.
• 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: Assists 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.

Qualifications

Required Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 5+ years of related Quality Assurance experience within the GMP-regulated industry, or 3+ years with a Master's degree.
• 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.

Preferred Qualifications

• Specialized knowledge of niche topics such as cell culture, QC methods, auditing techniques, barcoding, HEPA filtration science, etc.
• Prior experience interacting with regulatory agencies, representing technical deliverables, and hosting audit sessions.
• Experience with CMO oversight and compliance issues related to third-party vendors.
• ASQ certifications

Location and Working Environment

This position is based in Westborough, MA and will require on-site work. Occasional nights or weekend hours may be required to support operations.