Manager, Validation

Job Summary

We are seeking a Manager Validation to lead and oversee validation activities and Validation Quality Systems for sitelevel 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 Validation supports timely completion of validation documentation drives continuous improvement initiatives and serves as a subject matter expert for validation and electronic data integrity. This role partners closely 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.

About Our Validation Team

Youll join a dedicated Validation Team responsible for ensuring GMP systems are fit for intended use compliant and inspectionready. The team works crossfunctionally with operational and technical partners to support a growing and increasingly complex environment. Our approach emphasizes riskbased validation strong technical knowledge and continuous improvement. The environment is fastpaced highly collaborative and focused on delivering compliant businessready solutions.

Your Key Responsibilities

• 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 efficiency effectiveness and consistency of validation operations.

• Serve as a subject matter expert for validation practices and electronic data integrity requirements.

• Partner with crossfunctional 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.

Your Qualifications & Experience

Required:

• Bachelors degree (BS/BA) with 8 years of relevant industry experience or Masters degree with 6 years of relevant experience. Equivalent education and experience may be considered.

• Demonstrated experience in GMP validation within a regulated pharmaceutical or life sciences environment.

• Indepth 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.

• Handson experience with cloudbased and servicebased 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.

Preferred Skills & Competencies:

• 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.

Formalities

Location: Bothell WA

Schedule: Fulltime onsite

Compensation Range: $108080 - $148610