Senior Validation Lead — cGMP Compliance & Process Excellence

Guerbet; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet is seeking a senior Validation leader to guide the Validation department in ensuring cGMP compliance and high-quality execution of IQ/OQ/PQ across processes, equipment, and facilities.

You will manage internal staff and external contractors, drive the Validation Master Plan, and lead risk assessments, change controls, and GMP documentation with QA collaboration. Strong regulatory knowledge and leadership are essential for this role.

Qualifications

• Thorough knowledge of validation life cycle and IQ/OQ/PQ execution for equipment, utilities and facilities.
• Strong understanding of steam sterilization and cleaning validation.
• Proven leadership ability to manage internal staff and external contractors.
• Experience writing and reviewing GMP validation documentation and change controls.
• Ability to assess quality issues and implement CAPAs with QA oversight.
• Excellent communication with multiple stakeholders and audits.
• Familiarity with cGMP, FDA, ICH, EMEA and global regulatory expectations.

Responsibilities

• Lead day-to-day Validation department activities and team.
• Direct validation staff and contractors to meet schedules and budgets.
• Oversee Validation Master Plan and continuous improvement efforts.
• Create and enforce validation policies and procedures.
• Participate in internal and external audits and inspections.
• Coordinate risk assessments, change controls, protocols and reports.
• Manage revalidation programs for equipment, processes and cleaning.

Skills

Risk-based validation

Leadership

Project management

Equipment C&Q

sterilization & cleaning validation

Six Sigma/Lean

ICH QBD principles

21 CFR 11 awareness

Job description

Guerbet is seeking a senior Validation leader to guide the Validation department in ensuring cGMP compliance and high-quality execution of IQ/OQ/PQ across processes, equipment, and facilities.

You will manage internal staff and external contractors, drive the Validation Master Plan, and lead risk assessments, change controls, and GMP documentation with QA collaboration. Strong regulatory knowledge and leadership are essential for this role.