Job TitleAlston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office.
Job Description:
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:
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.
SalaryThe 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 be dependent on various factors, including but not limited to, the candidate's experience, education, relevant certifications, geographic location, market demands, and specific business needs. Generally, candidates are considered for the higher end of the salary range when they bring the requisite level of experience and expertise to the role.
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.
