Compliance Specialist at Astellas

Department: Astellas Institute for Regenerative Medicine

Compensation

$69,790 – $99,700/yr

Location: Westborough, Massachusetts
Type: Full-time
Level: mid
Posted: Sep 1, 2026

Summary from listing

Astellas is hiring a Compliance Specialist to support GMP manufacturing programs across clinical trials and commercialization. The role reviews QA documentation, supports deviation and CAPA investigations, assists with internal audits, contributes to continuous improvement, authors SOPs, and may oversee contract manufacturing organizations. The position is based in Westborough, Massachusetts, requires on-site work, and offers a salary range of $69,790 to $99,700 with medical, dental, and vision insurance.

Required Skills

GMP compliance
CAPA
Internal audit
Microsoft Office
Risk assessment

Additional Information

Minimum Education: Bachelor of Science or Bachelor of Arts in Life Sciences, Engineering, or Chemistry
Required Previous Experiences: 2-3 years of related Quality Assurance experience in a GMP-regulated industry
1-2 years of experience with a master's degree
6+ years of industry experience in biotechnological or pharmaceutical quality, manufacturing, or a related high-technical-aptitude industry
Preferred Qualifications: Knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy
Understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements
Ability to interpret regulatory rules and apply Quality-by-Design principles
Experience interacting with regulatory agencies and supporting audits
ASQ certification