FDA Technical Consultant

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 26 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 teams 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)

• 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

• Bachelors degree in chemistry biology pharmacy engineering or a related field

• 5 years experience an FDA investigator or a senior role in global quality

EQUAL OPPORTUNITY EMPLOYER

Alston & Bird LLP is an Equal Opportunity Employer does 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.

The statements contained in this position description are not necessarily all-inclusive additional duties and responsibilities may be assigned and requirements may vary from time to time.

Professional business references and a background screening will be required for all final applicants selected for a position.

If you need assistance or an accommodation due to a disability you may contact.

Alston & Bird is not currently accepting resumes from agencies for this position. If you are a recruiter search firm or employment agency you will not be compensated in any way for your referral of a candidate even if Alston & Bird hires the candidate.