Astellas Pharma · 1 week ago
Compliance Partner
Westborough, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$104K/yr - $148K/yr
8+ years expAstellas Pharma is a global pharmaceutical company dedicated to developing innovative therapies for patients. The Compliance Partner will ensure compliance with regulations governing animal research, biosafety, and controlled substances, while managing committee operations and regulatory reporting.
BiotechnologyHealth CareMedical
Responsibilities
Administrative management: Coordinating the schedules of the committees (IACUC/IBC), creating meeting agendas and materials, and maintaining all regulatory and administrative records
Protocol and amendments review: Managing the review and approval processes for research protocols (annual review and De Novo) and any amendments that are submitted to both committees. Additionally, assist in AAALAC reporting/accreditation, and post-approval monitoring
Compliance and training: Ensuring that all research activities adhere to relevant regulations, maintain training records, and remaining informed about guidelines from organizations such as AAALAC and NIH. Also, develop and deliver onboarding and continuing education for committees’ members
Researcher support: Serving as a point of contact between researchers and the committees, offering guidance on submissions, and assisting researchers in understanding compliance requirements
Policy development: Improving existing IACUC and IBC policies and guidelines while also assist in creating new ones as necessary for the IACUC and IBC programs
Database management: Manage Cayuse IACUC and IBC systems, troubleshoot issues, and collaborate with IS support
Track & Report Compliance Metrics: Maintain dashboards, review CAPA/Nonconformance/Unexpected Event records, and consolidate metrics across CGT sites
Lead SOP Harmonization & Audit Readiness: Harmonize SOPs and quality documents, develop inspection readiness plans, and execute mock audits/site inspection simulations
Advise & Educate Staff: Provide guidance on animal research compliance, ethics, and occupational health management
Qualification
Required
BS degree in animal health, biological science, or equivalent with 8 years of experience in research administration or compliance
Certified Professional in IACUC Administration (CPIA) as administered by PRIM&R
Strong communication skills and ability to work with diverse stakeholders
Proficiency in protocol management systems; Cayuse and Microsoft Office
Preferred
Experience in a GxP regulated environment or pharmaceutical/biotech industry
Project Management certification (PMP, CAPM) or pursuing certification
Knowledge of regulatory requirements related to facilities and laboratory operations
Experience with OLAW rules and regulations
Certified biosafety specialist with experience with virus and lab operations at BSL1, BSL2
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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-paid fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
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