Lead Compliance Specialist

Responsibilities include, but are not limited to, the following :

• Individual Contributor responsible for QA Compliance Strategy for clinical and pre-commercial cell and gene therapies.
• Serves as QA lead for clinical programs and initiatives related to new projects at AIRM.
• Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records.
• Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.

assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.

• Serves as a resource fluent in GMP Self-Inspection / Internal Audits for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.
• Oversees contract manufacturing organizations (CMOs), monitoring information requests, reviewing CMO work, and following up on compliance-related items.
• Develops compliant Quality processes and procedures to satisfy new compliance requirements and leads improvement of existing work practices.
• Aggregates and presents monthly metrics, identifying, planning, and executing continuous improvement opportunities for process efficiencies and compliance improvements to benefit department operations and / or the organization at large.

Requirements

Qualifications Required :

BS / BA, or equivalent, in Life Sciences, Engineering, or Chemistry with 7+ years of related Quality Assurance experience within GMP-regulated industry, or 5+ years with Masters degree.

In lieu of a Life Sciences, or equivalent, degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and / or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

• QA experience supporting biologics, cell therapy, and / or gene therapy
• Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.

Experience presenting these outcomes to management.

• Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
• Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred :

• Specialized knowledge of industry-related niche topics : bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
• Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
• Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.
• ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)

Working Conditions

This position is based in Westborough, MA and will require on-site work. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Benefits :

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 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
• Referral bonus program
30+ days ago