Global Pharma Site Validation Lead - GMP & Compliance

Cornerstone Recruiting; Baltimore (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Large Pharmaceutical Company in Baltimore seeks an experienced Validation leader to oversee, maintain, and manage the Site Validation Program. You will develop, revise, and execute Validation master plans, protocols, and annual reviews for equipment, systems, and processes, ensuring world-wide regulatory compliance.

You will train staff, coordinate with departments and outside vendors, and serve as SME during audits and inspections.

Qualifications

• 8–12 years of related experience within pharmaceutical industry.
• Minimum of 8 years Validation experience in the pharmaceutical industry including writing, executing, and summarizing Validation protocols and SOPs for equipment, systems, and processes.
• Minimum of 5 years Validation Management experience in the pharmaceutical industry.
• Experience with cleaning Validation and setting acceptance limits.
• Thorough knowledge of FDA, ICH, EU, PMDA and other global regulations and GMP guidelines associated with Validation requirements.
• Experience with/participation in FDA and other worldwide agency inspections.
• Validation SME in this area.

Responsibilities

• Oversees the site Validation program to ensure worldwide regulatory compliance at all times.
• Writes and is accountable for the execution of Validation/Revalidation protocols, reports, master plan, SOPs, FATs, Annual Validation Reviews, etc for equipment, systems, and processes in a timely and quality manner.
• Trains and oversees other site personnel in Validation protocol/SOP execution. Manages outside contractors as needed.
• Interacts with applicable departments and outside vendors to gather required information and ensure teams are well informed and compliant.
• Validation subject matter expert for all audits and inspections.
• Accountable for the site Validation program and is the area subject matter expert.

Skills

Regulatory knowledge

Validation management

Project management

Team leadership

Documentation writing

Vendor management

Kaye data logger

Education

B.S. degree in engineering, biology, pharmaceutics, or related science

Tools

Kaye data logger

Job description

Large Pharmaceutical Company in Baltimore seeks an experienced Validation leader to oversee, maintain, and manage the Site Validation Program. You will develop, revise, and execute Validation master plans, protocols, and annual reviews for equipment, systems, and processes, ensuring world-wide regulatory compliance.

You will train staff, coordinate with departments and outside vendors, and serve as SME during audits and inspections.