Senior Compliance Specialist
About The Position
The Senior Compliance Specialist performs advanced QA compliance tasks and provides oversight for GMP manufacturing programs as AIRM progresses through clinical trials and commercialization. The role helps maintain compliance across multiple Quality Assurance areas and collaborates with Manufacturing, Quality Control, and Materials Management teams to uphold quality standards and deliver patient value. The specialist makes compliance-related decisions with increasing independence and supports the leadership team on complex compliance initiatives. Responsibilities include reviewing manufacturing batch records, QC test records, raw material inspection records, and calibration records; leading deviation investigations and managing CAPAs; participating in GMP self-inspections; supporting contract manufacturing organization oversight; improving quality processes; mentoring less experienced staff; developing and revising SOPs; and analyzing and presenting compliance metrics. The position is based on-site in Westborough, Massachusetts. Occasional nights or weekend hours may be required.
Requirements
- BS/BA in Life Sciences, Engineering, or Chemistry with at least 5 years of related Quality Assurance experience in a GMP-regulated industry, or a Master's degree with at least 3 years of related experience.
- Strong knowledge of cGMP regulations for biotechnology, cell therapy, or gene therapy, including ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
- Experience conducting deviation investigations, root cause analysis, and CAPA effectiveness verification.
- Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Word.
- Ability to interpret regulatory rules, guidance, and industry standards to make objective, risk-based decisions and communicate them effectively to internal stakeholders.
- Strong written and verbal communication skills for generating reports and presenting compliance findings to senior leadership.
Nice To Haves
- Specialized knowledge of topics such as cell culture, QC methods, auditing techniques, barcoding, or HEPA filtration science.
- 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.
Responsibilities
- Independently review manufacturing batch records, QC test records, raw material inspection records, and calibration records; identify and address documentation errors and deviations from SOPs or specifications; track compliance metrics and provide periodic updates.
- Lead deviation investigations, identify root causes, and manage corrective and preventive actions (CAPA); support complex investigations and ensure compliance records are thorough, technically sound, and risk-based.
- Act as a lead participant in the GMP Self-Inspection program and collaborate across the organization to support adherence to domestic and international GMP regulations and Astellas procedures.
- Assist with oversight of contract manufacturing organizations by reviewing compliance-related documents, ensuring alignment with company standards, and following up on compliance issues or concerns.
- Identify, recommend, and help implement improvements to quality processes and procedures to improve operational efficiency and compliance.
- Mentor less experienced compliance staff and help troubleshoot complex quality issues.
- Lead the development and revision of SOPs and other quality documents to address new compliance requirements and improve existing practices.
- Aggregate, analyze, and present monthly compliance metrics; collaborate with senior compliance specialists and management on continuous improvement initiatives.
- Identify inefficiencies and potential compliance risks and propose solutions as part of continuous improvement initiatives.
- Work with Manufacturing, QC, and Materials Management teams to align compliance activities and identify and mitigate compliance risks.
Benefits
- Medical, dental, and vision insurance.
- Paid time off, including vacation and sick time, plus national holidays and a year-end shutdown.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
