Remote FDA Compliance & Inspection Consultant

Alston & Bird; Tacoma (WA); Hybride; USD 200 000 - 250 000; Plein temps

Résumé du poste

Alston & Bird LLP in Washington, DC is seeking an experienced FDA consultant to join the Health Care team and respond to FDA inspections at pharmaceutical and medical device sites. Flexible to work hybrid or fully remote.

Candidates should have 5+ years as FDA investigator or senior global quality role, strong regulatory knowledge (21 CFR Parts 210, 211 and ISO standards), and be ready for domestic and international travel to support inspections and remediation.

Qualifications

• Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related field.
• FDA experience required.
• Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality.
• 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.

Responsabilités

• Assist attorneys in supporting manufacturing clients on CGMP compliance.
• Prepare clients for inspections, provide inspection support (remote and on-site).
• Provide technical support for remediation efforts in response to FDA 483s, Warning Letters, and other enforcement actions.
• Extensive knowledge and experience related to quality systems, investigations, 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.

Connaissances

Interpersonal communication

Analytical skills

Time management

Travel willingness

Formation

Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related field

Outils

QMS (Quality Management Systems)

Description du poste

Alston & Bird LLP in Washington, DC is seeking an experienced FDA consultant to join the Health Care team and respond to FDA inspections at pharmaceutical and medical device sites. Flexible to work hybrid or fully remote.

Candidates should have 5+ years as FDA investigator or senior global quality role, strong regulatory knowledge (21 CFR Parts 210, 211 and ISO standards), and be ready for domestic and international travel to support inspections and remediation.