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Lead Compliance Specialist
2 months ago
We are seeking a highly skilled Lead Compliance Specialist to join our team at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA.
About the RoleThe Lead Compliance Specialist will play a critical role in ensuring the quality and compliance of our GMP manufacturing programs as we move through clinical trials and commercialization. This position will require strong knowledge of cGMPs, regulatory requirements, and quality assurance principles.
Key Responsibilities- Develop and implement QA compliance strategies for clinical and pre-commercial cell and gene therapies.
- Lead QA reviews of manufacturing batch records, QC test records, and other quality-related documents.
- Collaborate with cross-functional teams to investigate quality events and ensure compliance with regulatory requirements.
- Oversee contract manufacturing organizations (CMOs) and ensure compliance with Astellas procedures and regulations.
- Develop and maintain compliant quality processes and procedures.
- BS/BA in Life Sciences, Engineering, or Chemistry with 7+ years of related Quality Assurance experience in GMP-regulated industry.
- QA experience supporting biologics, cell therapy, and/or gene therapy.
- Demonstrated knowledge of cGMPs, ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
- Ability to interpret regulatory rules and make objective, risk-based decisions.
- Medical, Dental, and Vision Insurance.
- Generous Paid Time Off options.
- 401(k) match and annual company contribution.
- Company-paid life insurance.
- Annual Corporate Bonus and Quarterly Sales Incentive.
- Long Term Incentive Plan.
