GxP Compliance Manager

Title:

GxP Compliance Manager

Job Description:

Now Hiring: GxP Compliance Manager

Salary: $90,000-$100,000

Travel up to 25%

Job Overview

The GxP Compliance Manager is responsible for overseeing cleanroom cleaning operations, contamination control programs, and regulatory compliance within GxP cleanrooms, laboratories, and other controlled environments. This role ensures that all cleaning and disinfection activities are performed in accordance with current Good Manufacturing Practices (cGMP), approved Standard Operating Procedures (SOPs), validated cleaning methods, and applicable regulatory and safety requirements.

In addition to technical and compliance oversight, the GMP Compliance Manager is accountable for overall account performance, including, labor productivity, staffing, client satisfaction, contract compliance, and continuous operational improvement. The successful candidate will develop strong client partnerships, lead and develop site teams, maintain inspection-ready documentation, and ensure the consistent delivery of high-quality, compliant services within regulated life sciences environments.

Roles & Responsibilities

To perform this job successfully and safely, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

GMP Compliance & Contamination Control

• Oversee contamination control and environmental cleaning programs within cleanrooms, laboratories, and controlled environments.

• Ensure cleaning and disinfection activities are conducted using approved, validated methods in accordance with cGMP requirements, applicable standards, and site-specific procedures.

• Maintain accurate, complete, and audit-ready documentation, including cleaning logs, checklists, controlled records, and compliance reports.

• Develop, implement, review, and maintain SOPs, work instructions, and cleaning documentation to ensure consistent execution and regulatory compliance.

• Monitor adherence to contamination control protocols, cleaning validation requirements, and established quality standards.

• Support internal audits, client inspections, regulatory assessments, and corrective and preventive action (CAPA) activities as required.

• Identify compliance gaps, investigate deviations, and implement corrective actions to prevent recurrence and strengthen operational performance.

• Ensure employees receive appropriate training and demonstrate competency in GMP procedures, cleanroom protocols, chemical handling, and applicable OSHA safety requirements.

Financial & Business Performance

• Evaluate staffing models, labor utilization, and operational productivity to ensure resources align with contractual obligations and business objectives.

• Identify opportunities to improve operational efficiency, optimize labor deployment, and strengthen overall account performance.

Client Relationship & Contract Management

• Build and maintain strong client relationships to support customer satisfaction, service excellence, and long-term account retention.

• Maintain an active client stewardship program, engaging stakeholders at multiple organizational levels to review performance, address concerns, and identify opportunities for improvement.

• Monitor contract requirements and ensure service delivery meets or exceeds established contractual commitments, performance standards, and client expectations.

• Communicate program capabilities, service alternatives, and available corporate resources to address evolving client needs.

• Collaborate with clients and internal stakeholders to customize service delivery models and develop solutions that meet unique operational and compliance requirements.

• Proactively identify service concerns, resolve escalated issues, and implement sustainable action plans to protect client relationships and support account growth.

Leadership & Operational Excellence

• Lead, develop, and hold site personnel accountable for performance, productivity, safety, and compliance.

• Establish clear performance expectations and promote a culture of accountability, continuous improvement, and quality service delivery.

• Ensure staffing levels, employee qualifications, training, and scheduling support operational requirements and contractual commitments.

• Monitor key performance indicators (KPIs), identify performance trends, and implement improvement initiatives to strengthen service quality and efficiency.

• Partner with clients, corporate leadership, quality teams, and operational support functions to resolve challenges and achieve business objectives.

• Demonstrate initiative, sound judgment, adaptability, and effective decision-making in a highly regulated and changing environment.

Qualification

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other…