EMS Projects Lead - GMP & Quality Compliance

Biopharma Careers; Antwerpen; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson in Geel, Belgium is seeking an EMS Deskundige Projects to lead and support cross-functional projects within the EMS domain, ensuring compliant operations and site-wide improvements in GMP environments.

You will collaborate with QA, Operations, Engineering and QC labs, manage change controls and investigations, and drive safety, quality and regulatory compliance across facilities.

Qualifications

• Master's degree in microbiology, biotechnology, or related field.
• Experience leading GMP projects and change controls.
• Strong knowledge of cGMP regulations (FDA/EU) and GMP compliance.
• Experience in pharmaceutical production and QA/QC.
• Excellent collaboration and communication skills.
• Fluent in Dutch and English.

Responsibilities

• Act as EMS expert and central contact for cross-functional projects and site initiatives.
• Lead and support improvement initiatives for safety, compliance, quality and operations.
• Evaluate and execute change controls and associated qualification documentation.
• Lead investigations into incidents and define corrective actions.
• Contribute to GMP inspections and audits and track findings.
• Manage critical GMP documentation and EMS-related dossiers.
• Promote safety, quality, collaboration and accountability per our Credo.
• Build strong relationships with QA, Operations, Engineering & QC labs.

Skills

Project leadership

GMP compliance

QA collaboration

Regulatory knowledge

Stakeholder management

Communication

Fluent Dutch & English

Education

Master's degree in microbiology/biotechnology/chemistry

Job description

Johnson & Johnson in Geel, Belgium is seeking an EMS Deskundige Projects to lead and support cross-functional projects within the EMS domain, ensuring compliant operations and site-wide improvements in GMP environments.

You will collaborate with QA, Operations, Engineering and QC labs, manage change controls and investigations, and drive safety, quality and regulatory compliance across facilities.