GxP Compliance Manager

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Supervise contamination control and environmental sanitation initiatives within cleanrooms, laboratories, and regulated environments.

• Ensure that cleaning and disinfection processes utilize approved, validated techniques in compliance with cGMP standards, relevant regulations, and site-specific protocols.

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

• Develop, implement, review, and sustain SOPs, work instructions, and cleaning documentation.

• Monitor contamination control procedures, cleaning validation requirements, and quality benchmarks.

• Assist with internal audits, client inspections, regulatory evaluations, and CAPA initiatives.

• Identify compliance deficiencies, investigate deviations, and enact corrective measures.

• Ensure employee training and proficiency in GMP protocols, cleanroom procedures, chemical handling, and OSHA safety standards.

• Assess staffing models, labor efficiency, and operational productivity.

• Cultivate and sustain client relationships while managing contract obligations.

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

• Track KPIs and implement initiatives for improvement.

• Collaborate with clients, corporate leadership, quality teams, and operational support functions.

• Oversee supervisory duties, including interviewing, hiring, delegating tasks, performance assessments, disciplinary actions, addressing complaints, and resolving issues.

⛳️ Requirements

• Bachelor's degree in a relevant discipline or a comparable combination of education and professional experience.

• Proven experience in managing cleanroom cleaning, contamination control, environmental services, or similar operations within regulated facilities.

• Experience in managing client accounts, service contracts, and customer relations in a highly regulated setting.

• Familiarity with cGMP standards, cleanroom protocols, contamination control practices, SOP management, and audit-ready documentation.

• Demonstrated ability to lead teams, manage staffing and productivity, and drive operational enhancements.

• Strong verbal and written communication skills, with the capability to present operational and financial outcomes to clients and senior leadership.

• Exceptional organizational, analytical, and problem-solving abilities.

• Knowledge of contract management, performance oversight, and standard business procedures.

• Capacity to lift and/or move up to 35 pounds.

• A valid driver's license may be necessary based on business requirements; employees who drive must maintain an acceptable MVR and adhere to company driving eligibility standards.

🏝️ Benefits

• Comprehensive benefit packages.

• Equal employment opportunity workplace.