Remote FDA Compliance Strategist

Alston & Bird; Washington (District of Columbia); Ibrido; USD 200.000 - 250.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid/Remote work flexibility

Descrizione del lavoro

Alston & Bird seeks an experienced FDA consultant to support the Health Care team's FDA practice from the Washington, D.C. Office. The role requires at least 5 years in FDA investigations or senior global quality roles, with travel and potential remote work options.

Ideal candidates will assist with CGMP compliance, inspection readiness, and remediation for FDA actions, collaborating with legal, regulatory, quality, and manufacturing teams. Strong communication and problem-solving are essential.

Competenze

• 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.

Mansioni

• 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

Conoscenze

FDA experience

CGMP compliance

Regulatory inspections

Cross-functional collaboration

Travel readiness

Formazione

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

Descrizione del lavoro

Alston & Bird seeks an experienced FDA consultant to support the Health Care team's FDA practice from the Washington, D.C. Office. The role requires at least 5 years in FDA investigations or senior global quality roles, with travel and potential remote work options.

Ideal candidates will assist with CGMP compliance, inspection readiness, and remediation for FDA actions, collaborating with legal, regulatory, quality, and manufacturing teams. Strong communication and problem-solving are essential.