GxP Compliance & Cleanroom Lead

SBM Management Services, LP; New Jersey; Híbrido; USD 90 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Benefits package

Resumo da oferta

SBM Management Services, LP seeks a GxP Compliance Manager to oversee cleanroom cleaning, contamination control, and regulatory compliance across GxP environments. You will ensure adherence to cGMP, SOPs, validated methods, and safety requirements while maintaining audit-ready documentation.

You will lead site teams, manage staffing and training, and drive continuous improvement to meet contractual obligations and client expectations.

Qualificações

• 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.

Responsabilidades

• Oversee contamination control and environmental cleaning programs in cleanrooms, laboratories, and controlled environments.
• Ensure cleaning and disinfection activities are conducted using approved, validated methods in accordance with cGMP requirements and SOPs.
• Maintain audit-ready documentation, including cleaning logs, checklists, 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 CAPA activities as required.
• Identify compliance gaps and implement corrective actions to strengthen performance.
• Ensure training and competency of employees in GMP procedures and safety requirements.

Conhecimentos

GxP compliance

cGMP knowledge

SOP development

Documentation management

Leadership

Training & competency

Formação académica

Bachelor's degree in a relevant field

Descrição da oferta de emprego

SBM Management Services, LP seeks a GxP Compliance Manager to oversee cleanroom cleaning, contamination control, and regulatory compliance across GxP environments. You will ensure adherence to cGMP, SOPs, validated methods, and safety requirements while maintaining audit-ready documentation.

You will lead site teams, manage staffing and training, and drive continuous improvement to meet contractual obligations and client expectations.