GxP Compliance Manager

SBM Offshore•Hillsboro, OR

2d•$90,000 - $100,000

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 overall account performance, including labor productivity, staffing, client satisfaction, contract compliance, and continuous operational improvement. This role develops client partnerships, leads and develops site teams, maintains inspection-ready documentation, and ensures high-quality, compliant services in regulated life sciences environments. The role includes management responsibilities such as interviewing, hiring, planning and directing work, conducting performance evaluations, recognizing and disciplining employees, resolving complaints and problems, and ensuring employees are trained on tasks and safety requirements. Travel may be 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.
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.
Strong organizational, analytical, and problem-solving skills, including the ability to prioritize competing demands and manage multiple responsibilities.
Demonstrated leadership, initiative, flexibility, accountability, and professionalism.
Working knowledge of contract administration, performance management, and standard business procedures.
A valid driver's license may be required based on business needs; employees who drive for work must maintain an acceptable Motor Vehicle Record and meet company driving eligibility requirements.
Ability to sit and talk or listen frequently and lift and/or move up to 35 pounds.
Travel up to 25%.

Responsibilities

Oversee contamination control and environmental cleaning programs in cleanrooms, laboratories, and controlled environments.
Ensure cleaning and disinfection use approved, validated methods consistent with cGMP requirements, applicable standards, and site-specific procedures.
Maintain accurate, complete, and audit-ready cleaning logs, checklists, controlled records, and compliance reports.
Develop, implement, review, and maintain SOPs, work instructions, and cleaning documentation.
Monitor adherence to contamination control protocols, cleaning validation requirements, and quality standards.
Support internal audits, client inspections, regulatory assessments, and corrective and preventive action (CAPA) activities.
Identify compliance gaps, investigate deviations, and implement corrective actions to prevent recurrence.
Ensure employees receive training and demonstrate competency in GMP procedures, cleanroom protocols, chemical handling, and applicable OSHA safety requirements.
Evaluate staffing models, labor utilization, and operational productivity against contractual obligations and business objectives.
Identify opportunities to improve operational efficiency, optimize labor deployment, and strengthen account performance.
Build and maintain client relationships to support satisfaction, service excellence, and account retention.
Maintain a client stewardship program, engaging stakeholders to review performance, address concerns, and identify improvements.
Monitor contract requirements and ensure service 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 customize service delivery models and develop solutions for operational and compliance requirements.
Identify service concerns, resolve escalated issues, and implement sustainable action plans to 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 levels, qualifications, training, and scheduling support 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 achieve business objectives.
Interview, hire, plan, assign, and direct work; conduct performance evaluations; reward and discipline employees; and address complaints and resolve problems.