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Washington, District of Columbia, United States
Hybrid
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 the designation as 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.
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.
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 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 EMPLOYMENT OPPORTUNITY
Alston & Bird LLP is an equal opportunity employer. We are committed to providing equal employment opportunities to all applicants and employees and prohibit discrimination or harassment on the basis of race, color, religion, national origin, ancestry, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.
This commitment applies to all aspects of employment, including recruitment, hiring, compensation, benefits, training, promotion, transfer, discipline, and termination.
Alston & Bird also provides reasonable accommodations to qualified applicants and employees with disabilities and to individuals who require an accommodation based on religion, pregnancy, childbirth, or related medical conditions, as required by applicable law. Applicants who need a reasonable accommodation during the application or hiring process may contact donavan.mclean@alston.com.
PRE-EMPLOYMENT SCREENING
Employment may be contingent upon the successful completion of applicable pre-employment screening, which may include professional references and a background screening, consistent with applicable law.
SEARCH FIRMS AND EMPLOYMENT AGENCIES
Alston & Bird does not accept unsolicited resumes or candidate referrals from recruiters, search firms, or employment agencies. Any resume or candidate information submitted without a prior written agreement with Alston & Bird will be considered unsolicited, and no fee will be paid if the candidate is hired.
