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Compliance Partner

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose:

As a member of the Facilities Engineering & Logistics (FEL) Compliance team, the Compliance Partner plays a critical role in ensuring compliance with federal, state, and institutional regulations governing animal research, biosafety, and controlled substances. This position supports the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC), leading protocol review, committee operations, and regulatory reporting.

Essential Job 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.

Q** **ualifications

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, BSL2 **Working Conditions:**

+ This position is located in Westborough, MA and will require on-site work with ability to work in a hybrid work environment.

**Salary Range:** $103,600-148,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations).

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

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Category Facilities, Engineering and Logistics

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans