Remote: Associate Director, GxP Quality Auditor

Valid8 Financial, Inc.; Kentucky; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Stock options

Paid time off (PTO)

Competitive benefits

Job summary

Cabaletta Bio is seeking an Associate Director, GxP Quality Auditor to lead quality audits across external CDMOs, clinical sites, and internal labs. This role reports to the Audits Director and requires strategic thinking to implement audit strategies that comply with regulatory requirements.

The ideal candidate has extensive GxP auditing experience in biopharma and can drive CAPA activities, risk assessments, and investigations while mentoring junior staff.

Qualifications

• Minimum bachelor’s degree in any scientific discipline.
• A minimum of 5-7 years of biopharmaceutical experience including a minimum of 3 years of GxP auditing in a regulated environment focused on quality, CGT preferred.
• Excellent knowledge of GxP regulatory requirements.
• Experience using electronic Quality Management Systems.
• Auditor certification, preferred.
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to understand when issues require escalation to Senior Quality Management.
• Must be detail oriented; must be precise and organized in handling of documents.

Responsibilities

• Function as a Quality/GxP auditor for external CDMOs, clinical sites, and internal laboratory operations.
• Implement the global audit strategy in line with regulatory requirements.
• Perform audits across various departments and functional areas.
• Conduct risk assessments to identify potential concerns and develop audit plans.
• Review internal controls and recommend improvements to mitigate risks.
• Collaborate with cross-functional teams to ensure audit findings are addressed.
• Stay updated with regulatory changes and emerging risks impacting the organization.
• Conduct investigations into fraud or non‑compliance and recommend actions.
• Prepare audit reports with findings and action plans for management.
• Provide training and coaching on audit-related matters.

Skills

GxP auditing

Biopharmaceutical knowledge

Quality Assurance

Root cause analysis

Education

Bachelor’s degree in a scientific discipline

Tools

Electronic Quality Management Systems

Job description

Cabaletta Bio is seeking an Associate Director, GxP Quality Auditor to lead quality audits across external CDMOs, clinical sites, and internal labs. This role reports to the Audits Director and requires strategic thinking to implement audit strategies that comply with regulatory requirements.

The ideal candidate has extensive GxP auditing experience in biopharma and can drive CAPA activities, risk assessments, and investigations while mentoring junior staff.