GMP Project Manager (m/w/d)

GMP Project Manager (M/F/D)

Tasks:

• Review and optimize the existing remediation plan for FDA compliance.
• Lead the day-to-day project execution and timeline tracking.
• Coordinate and follow up with internal stakeholders to ensure the timely delivery of action items.
• Ensure GMP compliance across remediation areas such as:
• Equipment cleaning and maintenance
• Labelling issuance processes
• Equipment inspections (automatic, mechanical, electronic)
• Laboratory records and data integrity
• Microbiological lab operations and water system monitoring
• Deviation management and system improvements
• Storage of plastic resins
• Equipment and system validation (e.g., autoclaves, ERP, UPS/generator)
• Air supply compressors and backup systems

• Maintain documentation, risk tracking, and clear status reporting.

   

Qualification:

• 10+ years in Quality Assurance or Quality Systems within pharma manufacturing, ideally in sterile products or ophthalmology.
• Proven experience in FDA-facing GMP remediation projects.
• Expert-level understanding of 21 CFR Parts 210/211, ICH Q10, and data integrity expectations.
• Hands-on experience with audits, deviations, CAPAs, validation, and lab/GMP documentation.
• Experience working with or within CMOs.
• Strong project management and cross-functional leadership skills.
• Self-driven, persistent, detail-oriented.
• Fluent in English; based in European time zones.

Requirements: 

Start: asap

Duration: 6-12 months

Capacity: 3-5 days per week

Location: remote