Quality Consultant

GMP Quality Consultant (On-site)

Location: Redmond, WA (2-3 days/week onsite at External Manufacturing Partner)

Duration: 12 months (renewable)

Overview

Our client is seeking a GMP Operational Quality Consultant to serve as the on-site Quality representative (Person-in-Plant) at an external biologics manufacturing partner. This individual will provide quality oversight during manufacturing operations, ensure GMP compliance, support operational readiness activities, and act as the primary liaison between internal stakeholders and the CMO. The ideal candidate will bring a combination of Quality Assurance, GMP manufacturing, and validation experience within biologics and/or combination product environments.

Responsibilitie

• sServe as the on-site Quality representative (PIP) at a contract manufacturing organization (CMO)
• .Provide GMP floor support and quality oversight during biologics manufacturing campaigns
• .Partner with internal and external stakeholders to ensure compliance, operational readiness, and successful execution of manufacturing activities
• .Support and manage quality systems activities including deviations, investigations, CAPAs, change controls, and documentation review
• .Review and revise quality system documentation within Veeva Vault QMS
• .Monitor supplier quality performance and escalate compliance risks as needed
• .Support batch execution, GMP documentation review, batch release activities, and inspection readiness efforts
• .Collaborate closely with Manufacturing, Validation, Supply Chain, Regulatory, and Quality teams to drive issue resolution and maintain production schedules

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Qualificatio

• nsBS degree minimum; 8 years of Quality Assurance experience within biopharma, biologics, or combination product environment
• s.Strong operational QA background supporting GMP manufacturing operation
• s.Experience working directly with CMOs, suppliers, or external manufacturing partner
• s.Experience supporting deviations, investigations, CAPAs, change controls, and quality system
• s.Hands-on experience with Veeva Vault QM
• S.Strong communication and stakeholder management skill
• s.Ability to independently assess issues, drive resolution, and communicate recommendations to leadershi

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Preferred Qualificati

• onsPrior Person-in-Plant (PIP) experien
• ce.Combination of QA, Validation, and Manufacturing experien
• ce.Direct biologics manufacturing experien
• ce.Product launch, inspection readiness, or commercial manufacturing support experien
• ce.Experience supporting combination produc