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 duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education and/or Experience

Bachelor's degree in a relevant field or equivalent combination of education and professional experience.

Demonstrated experience managing cleanroom cleaning, contamination control, environmental services, or related operations within regulated facilities.

Experience managing client accounts, service contracts, and customer relationships in a highly regulated environment.

Certificates, Licenses, Registrations

A valid driver's license may be required for this position based on business needs. Employees required to drive as part of their job duties must maintain an acceptable Motor Vehicle Record (MVR) and meet company driving eligibility requirements.

Knowledge, Skills, and Abilities

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 the ability to present operational and financial results to clients and senior leadership.

Excellent organizational, analytical, and problem-solving skills, with 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.

Supervisory Responsibilities

Carries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, planning, assigning, and directing work; performance evaluations; rewarding and disciplining employees; addressing complaints and resolving problems. Ensure employees are properly trained on tasks and safety requirements.

Physical Demands & Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or listen. The employee must be able to lift and/or move up to 35 pounds.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.