FDA Technical Consultant

Alston & Bird • Washington, DC

2d • Hybrid

About The Position

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.

Requirements

• Regular travel within the United States and Internationally. Regular travel 1-2 weeks a month with flexibility for more.
• Ability to organize and prioritize numerous tasks and complete them under time constraints.
• Interpersonal skills necessary in order to communicate and follow instructions effectively from a diverse group of clients, attorneys and staff and provide information with ordinary courtesy and tact.
• Work typically requires more than 40 hours per week to perform the essential duties of the position; may require irregular hours.
• Ability to travel to private and public buildings, domestically and internationally, via private or public conveyance to assist attorney in attending to client needs on legal matters.
• Bachelor’s degree in chemistry, biology, pharmacy, engineering, or a related field
• 5+ years' experience an FDA investigator or a senior role in global quality

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)
• Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other enforcement actions
• Extensive knowledge and experience related to quality systems, investigations, Corrective & Preventative Actions (CAPAs), contamination control, cleaning validation, and data integrity are essential for this role
• Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory, quality, manufacturing, and executive leadership teams
• Draft memos regarding the status of projects
• Maintain current and accurate daily time record
• Perform special projects as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees