GxP Compliance Lead for Cleanrooms & GMP

SBM Management Services, LP

Hillsboro (OR)

On-site

USD 90,000 - 100,000

Full time

4 days ago

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Job summary

SBM Management Services, LP is seeking a GxP Compliance Manager to oversee cleanroom cleaning operations, contamination control programs, and regulatory compliance in GMP environments. The role ensures activities follow cGMP, SOPs, and validated methods, while maintaining audit-ready documentation and leading site teams.

You will manage client relationships, drive operational performance, and coach staff to achieve contract goals, with travel up to 25%.

Qualifications

Bachelor's degree in a relevant field; equivalent combination allowed.
Experience managing cleanroom cleaning, contamination control, or related regulated operations.
Experience managing client accounts and service contracts in regulated environments.
Knowledge of cGMP, SOP management, and audit-ready documentation.
Strong communication and leadership skills.

Responsibilities

Oversee GMP compliance and contamination control in cleanrooms and labs.
Ensure cleaning and disinfection follow validated methods and cGMP requirements.
Maintain audit-ready documentation and records.
Develop and maintain SOPs, work instructions, and cleaning docs.
Support internal audits, client inspections, CAPA activities.
Identify compliance gaps and implement corrective actions.
Train employees on GMP procedures and safety.
Manage staffing, productivity, and contract performance.
Lead site personnel and drive continuous improvement.