GxP Compliance Manager

SBM Management Services•Hillsboro, OR

About The Position

The GxP Compliance Manager oversees cleanroom cleaning operations, contamination control programs, and regulatory compliance in GxP cleanrooms, laboratories, and other controlled environments. The role ensures cleaning and disinfection follow current Good Manufacturing Practices (cGMP), approved Standard Operating Procedures (SOPs), validated cleaning methods, and applicable regulatory and safety requirements. The manager is also accountable for account performance, including labor productivity, staffing, client satisfaction, contract compliance, and continuous operational improvement. The position develops client partnerships, leads site teams, maintains inspection-ready documentation, and delivers compliant services in regulated life sciences environments. Travel is up to 25%.

Requirements

Bachelor's degree in a relevant field or an equivalent combination of education and professional experience.
Demonstrated experience managing cleanroom cleaning, contamination control, environmental services, or related operations in regulated facilities.
Experience managing client accounts, service contracts, and customer relationships in a highly regulated environment.
Working knowledge of cGMP requirements, cleanroom protocols, contamination control practices, SOP management, and audit-ready documentation.
Proven ability to lead teams, manage staffing and productivity, and drive operational improvements.
Strong written and verbal communication skills, including presenting operational and financial results to clients and senior leadership.
Excellent organizational, analytical, and problem-solving skills, including prioritizing competing demands and managing multiple responsibilities.
Demonstrated leadership, initiative, flexibility, accountability, and professionalism.
Working knowledge of contract administration, performance management, and standard business procedures.
Ability to meet the physical demands of the role, including frequently sitting and talking or listening and lifting or moving up to 35 pounds.
A valid driver's license may be required based on business needs; employees who drive for work must maintain an acceptable MVR and meet company driving eligibility requirements.

Responsibilities

Oversee contamination control and environmental cleaning programs in cleanrooms, laboratories, and controlled environments.
Ensure cleaning and disinfection follow approved, validated methods, cGMP requirements, applicable standards, and site procedures.
Maintain complete, accurate, audit-ready cleaning logs, checklists, controlled records, and compliance reports.
Develop, implement, review, and maintain SOPs, work instructions, and cleaning documentation.
Monitor compliance with contamination control protocols, cleaning validation requirements, and quality standards.
Support internal audits, client inspections, regulatory assessments, and CAPA activities.
Identify compliance gaps, investigate deviations, and implement corrective actions to prevent recurrence.
Ensure employees receive appropriate training and demonstrate competency in GMP procedures, cleanroom protocols, chemical handling, and OSHA safety requirements.
Evaluate staffing models, labor utilization, and productivity to align resources with contracts and business objectives.
Identify opportunities to improve efficiency, labor deployment, and account performance.
Build and maintain client relationships to support satisfaction, service excellence, and account retention.
Maintain a client stewardship program, review performance with stakeholders, address concerns, and identify improvement opportunities.
Monitor contract requirements and ensure service delivery meets contractual commitments, performance standards, and client expectations.
Communicate program capabilities, service alternatives, and corporate resources to address client needs.
Collaborate with clients and internal stakeholders to tailor service models and solutions to operational and compliance requirements.
Identify service concerns, resolve escalated issues, and implement action plans that protect client relationships and support account growth.
Lead, develop, and hold site personnel accountable for performance, productivity, safety, and compliance.
Establish performance expectations and promote accountability, continuous improvement, and quality service delivery.
Ensure staffing, qualifications, training, and scheduling meet operational requirements and contractual commitments.
Monitor KPIs, identify performance trends, and implement initiatives to improve service quality and efficiency.
Partner with clients, corporate leadership, quality teams, and operational support functions to resolve challenges and meet business objectives.
Exercise initiative, judgment, adaptability, and effective decision-making in a regulated and changing environment.
Interview, hire, plan, assign, and direct work; conduct performance evaluations; reward and discipline employees; address complaints and resolve problems.
Ensure employees are properly trained on tasks and safety requirements.