Specialist, QA Validation

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

Role

This is an Onsite role in Sanford, NC. The Specialist, QA Validation is responsible for providing quality assurance oversight and support for the commissioning, qualification, and validation (CQV) activities across the site. This role ensures that all validation efforts comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The position collaborates cross-functionally with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.

Responsibilities

• Provide QA oversight and support for CQV activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems, and manufacturing process.
• Evaluate and approve qualification / validation discrepancies and corrective / preventive actions (CAPAs).
• Provide QA oversight periodic review and lifecycle management activities for validated systems and computerized systems. Support revalidation as required by lifecycle management or change control.
• Review and approve change management documentation including Engineering Change Management, Automation Change Management, and general Change Controls.
• Promote and maintain a strong cGMP quality culture across the organization.
• Ensure adherence to local and global quality standards, regulatory requirements, and industry best practices.
• Participate in internal and external audits, including regulatory inspections (e.g., FDA, EMA, DHHS) and third-party or corporate partner audits.

Required Qualifications

Preferred Qualifications

Benefits

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Category BioPharma QA

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

EOE including Disability / Protected Veterans

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