Hogan Lovells Cadwalader is an international law firm with an award-winning Life Sciences practice. Our Global Pharmaceutical and Biotechnology practice focus on supporting companies throughout the product lifecycle, including manufacturing, compliance, and post-market oversight. Our practice includes a unique blend of attorneys and technical experts with advanced scientific degrees (e.g., chemistry, microbiology, engineering, pharmaceutical sciences) as well as professionals who previously served in key roles at FDA, including investigators, compliance officers, and the Director of the Office of Compliance. Many of our attorneys previously served in FDA’s Office of the Chief Counsel and in leadership positions at FDA and the Department of Health and Human Services.
We assist our clients in developing regulatory and compliance strategies, particularly in navigating Current Good Manufacturing Practice (CGMP) requirements for drugs and biologics. Our team advises on manufacturing compliance, inspection readiness, enforcement risk mitigation, and regulatory submissions related to quality systems. The position offers the opportunity to join a prestigious group addressing complex manufacturing and quality challenges in the FDA-regulated industry.
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
Work Arrangement
This position may be based remotely or in a hybrid work arrangement , depending on candidate preference and proximity to Hogan Lovells Cadwalader offices
Candidates must demonstrate strong attention to detail, proactive problem-solving skills, and the ability to manage multiple…