FDA Technical Consultant

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
• SKILLS NEEDED TO BE SUCCESSFUL
• 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.
• EDUCATION & EXPERIENCE
• Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related field.
• FDA experience required.
• Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance.
• In-depth knowledge of quality systems, regulatory requirements (21 CFR Parts 210, 211 and related guidance), quality management systems (QMS), and ISO standards.
• Strong analytical skills with a focus on root cause analysis and problem-solving.
• Excellent written and verbal communication skills, enabling effective interaction with various stakeholders.
• Proficient in using quality management systems and documentation tools.
• Ability to provide exceptional client service and manage multiple engagements in a fast-paced environment.
• Willingness to frequently travel to international and domestic client sites to support inspections, audit, and remediation activities.
• EQUAL OPPORTUNITY EMPLOYER

Benefits

Additional Information

THE FIRM As a leading international law firm, we are dedicated to excellence through impactful communication, collaboration, and community involvement. Our company culture has earned us one of the "100 Best Companies to Work For" for 27 consecutive years. This honor, along with many others, highlights our commitment to innovation and professional development. At Alston & Bird LLP, our foundation is made of trust, reliability, and compassion. 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.

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