Usa Alston & Bird

Alston & Bird LLP 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 of experience as an FDA investigator or in a senior global quality role to assist the FDA team in responding to FDA inspections at pharmaceutical and medical device manufacturing sites. This role offers flexibility to work hybrid or fully remote and may require extended hours, regular domestic and international travel, and the ability to work beyond 40 hours per week.

Key Responsibilities

Assist attorneys in supporting manufacturing clients on issues related to Current Good Manufacturing Practices (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 Apply extensive knowledge of quality systems, investigations, corrective & preventive actions (CAPAs), contamination control, cleaning validation, and data integrity 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 and maintain current accurate daily time records Perform special projects as assigned Skills Needed to be Successful Regular travel within the United States and internationally (1–2 weeks a month with flexibility for more) Ability to organize and prioritize numerous tasks and complete them under time constraints Strong interpersonal skills to communicate and follow instructions effectively from a diverse group of clients, attorneys, and staff Prepared to work more than 40 hours per week and accommodate irregular hours Ability to travel to private and public buildings domestically and internationally via private or public conveyance 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 senior industry 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 focused on root cause analysis and problem solving. Excellent written and verbal communication skills. Proficiency 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, audits, and remediation activities. Salary The salary range for this position in Washington, D.C. is $200,000–$250,000 and represents the firm's good‐faith minimum and maximum range for this role at the time of posting.

The actual salary offered will depend on factors such as experience, education, certifications, geographic location, market demands, and business needs. Equal Opportunity Employer Alston & Bird LLP is an Equal Opportunity Employer that does not discriminate on the basis of any status protected under federal, state, or local law.

Applicants will be considered regardless of their sex, race, age, religion, color, national origin, ancestry, physical disability, mental disability, medical condition (associated with cancer, a history of cancer, or genetic characteristics), HIV/AIDS status, genetic information, marital status, sexual orientation, gender, gender identity, gender expression, military and veteran status, or other protected category under the law.