FDA Technical Consultant

About the role

The Firm is a leading international law firm committed to excellence through impactful communication, collaboration, and community involvement. It has been recognized as one of the "100 Best Companies to Work For" for 26 consecutive years, highlighting its commitment to innovation and professional development.

Responsibilities

• Aid attorneys in supporting manufacturing clients on CGMP compliance issues
• Support clients during inspections, both remotely and on-site
• Offer technical support for remediation efforts in response to FDA inspections
• Collaborate with cross-functional teams including legal, regulatory, quality, manufacturing, and executive leadership
• Draft memos regarding project statuses
• Maintain accurate daily time records
• Assist with special projects as assigned

Skills Needed to Be Successful

• Regular travel within the United States and Internationally
• Ability to organize and prioritize numerous tasks
• Interpersonal skills for effective communication with diverse groups
• Ability to work more than 40 hours per week and travel as needed
• Knowledge and experience in quality systems, investigations, CAPAs, contamination control, cleaning validation, and data integrity

Education & Experience

• Bachelor’s degree in chemistry, biology, pharmacy, engineering, or a related field
• At least 5 years' experience as an FDA investigator or a senior role in global quality

Pay

The salary range for this position in Washington D.C. is $200,000-$250,000 and is contingent upon various factors including experience, education, relevant certifications, geographic location, market demands, and specific business needs.

Equal Opportunity Employer

Alston & Bird LLP is an Equal Opportunity Employer. We do not discriminate on the bases 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 on the basis of race, color, religion, sex, age, sexual orientation, gender identity and/or expression, national origin, veteran status or disability in relation to our recruiting, hiring, and promoting practices.