FDA CGMP Expert

Hogan Lovells Cadwalader, an international law firm, seeks an FDA CGMP Expert to join their Global Pharmaceutical and Biotechnology practice. The successful candidate will provide expert guidance on FDA CGMP requirements applicable to drug and biologic manufacturing.

Responsibilities:

• Provides expert guidance on FDA CGMP requirements applicable to drug and biologic manufacturing (21 CFR Parts 211, 212, 600), including interpretation and implementation
• Advises clients on compliance with FDA regulations, inspection readiness, and post-inspection remediation strategies, including ability to conduct mock FDA inspections
• Assesses manufacturing facilities, quality systems, and documentation to identify compliance risks and recommend corrective and preventive actions (CAPAs)
• Supports clients in responding to FDA inspectional observations (Form FDA 483s), Warning Letters, regulatory meetings, and other enforcement actions
• Assists in developing and revising quality systems documentation, including SOPs, batch records, deviation investigations, and validation protocols
• Works closely with client cross-functional teams (e.g., Quality Assurance, Manufacturing, Regulatory Affairs, Engineering) to ensure compliance across operations
• Provides strategic advice during FDA inspections and may participate in inspection preparation and mock audits
• Advises on data integrity, contamination control, process validation, equipment qualification, and supplier quality management
• Monitors evolving FDA policies, guidance documents, and enforcement trends related to CGMP compliance

Qualifications:

• Bachelor’s, MS, or PhD degree in a relevant scientific or engineering discipline (e.g., pharmaceutical sciences, chemistry, microbiology, chemical/biomedical engineering)
• Minimum of 5+ years of experience as an FDA Investigator, with direct experience conducting inspections of drug and/or biologics manufacturing facilities
• Deep knowledge of FDA CGMP regulations, inspection processes, and enforcement actions related to pharmaceutical manufacturing
• Strong understanding of quality systems, including CAPA, deviation management, validation, and data integrity principles
• Experience reviewing manufacturing operations, laboratory controls, and quality assurance systems
• Familiarity with FDA regulatory submission requirements for CMC (Chemistry, Manufacturing, and Controls) sections
• Excellent written and verbal communication skills, including the ability to clearly explain complex regulatory requirements
• Ability to work collaboratively with multidisciplinary teams across different functional areas and jurisdictions
• Willingness and ability to travel at least 25% of the time, including international travel

Benefits:

• Salary is commensurate with experience
• Eligible for additional forms of compensation, which may include annual performance bonuses and discretionary bonuses
• Medical, dental, and vision insurance
• 401(k) retirement plan
• Paid time off
• Relocation assistance may be available