Manager, Validation

Join Us in Bringing Hope to Life. Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. We rely on team members who value excellence, collaboration, and meaningful work.

The Manager, Validation leads and oversees validation activities and the Validation Quality Systems for site‑level GMP systems. This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements. The Manager supports timely completion of validation documentation, drives continuous improvement initiatives, serves as a subject‑matter expert for validation and electronic data integrity, partners with Manufacturing, Engineering, IT, Quality and external vendors, and plays a key role in supporting regulatory inspections.

The position also provides leadership, coaching and development for members of the Validation team.

• Lead and support the completion of GMP validation documentation for site systems, ensuring milestones and deliverables are met on agreed timelines.
• Oversee the implementation and maintenance of Validation Quality Systems, including policies, procedures, guidance documents, training and tools.
• Monitor and maintain controls, procedures, and guidance that define and align validation activities for both internal and external GMP systems.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and consistency of validation operations.
• Serve as a subject‑matter expert for validation practices and electronic data integrity requirements.
• Partner with cross‑functional stakeholders—including IT, Engineering, Manufacturing, Quality and external vendors—to support validation activities.
• Support regulatory inspections and audits related to validation and computerized systems.
• Provide coaching, performance feedback and professional development to Validation team members.
• Ensure validation strategies and execution align with FDA, EMA and other global health authority expectations.

• Bachelor’s degree (BS/BA) with 8+ years of relevant industry experience, or Master’s degree with 6+ years of relevant experience.
• Demonstrated experience in GMP validation within a regulated pharmaceutical or life‑sciences environment.
• In‑depth knowledge of global regulatory expectations related to validation, computerized systems and electronic records.
• Demonstrated subject‑matter expertise in validation and IT systems compliance as defined by pharmaceutical regulatory authorities.
• Hands‑on experience with cloud‑based and service‑based system validation and Computer Software Assurance (CSA), including systems such as ERP, LIMS and QMS.
• Ability to work flexible hours as needed to support network and operational requirements.

• Strong facilitation and project management skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills.
• Strategic understanding of validation lifecycle activities and electronic record/data integrity requirements.
• Exceptional stakeholder and customer interface skills.
• Proven ability to lead, coach and develop validation professionals.

Location:

Bothell, WA

Schedule:

Full‑time, onsite
Compensation Range: $108,080 – $148,610

AGC Biologics is a global Contract Development and Manufacturing Organization located in Bothell, Washington. We develop and manufacture advanced biologics for innovative pharmaceutical companies worldwide. Our team is collaborative, inclusive and values expertise, teamwork and ingenuity.