JOB DESCRIPTION

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team’s FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years’ experience as an FDA investigator or a senior role in global quality, to assist our FDA team in responding to FDA inspections at pharmaceutical and medical device manufacturing sites. This role offers flexibility to work hybrid or a fully remote arrangement. Candidates should be self-starters, highly organized, and team players. Extended hours and regular domestic and international travel are often needed to meet client deadlines. ​

Key Responsibilities

• Assist attorneys in supporting manufacturing clients on issues related to Current Good Manufacturing Processes (CGMP) compliance

• Prepare clients for inspections, provide inspection support (remote and on-site)

• Pr...