Associate Director, GxP Quality Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and execute scheduled quality audits for external CDMOs, clinical sites, and internal laboratory operations.

• Apply the global audit strategy to align with organizational objectives and regulatory standards.

• Conduct audits across various departments and functional areas.

• Carry out risk assessments and formulate audit plans and procedures.

• Evaluate internal controls and propose enhancements to mitigate risks and improve processes.

• Collaborate with finance, operations, compliance, legal, and other cross-functional teams to address audit findings.

• Investigate instances of fraud, unethical practices, non-compliance, and internal audit results.

• Prepare comprehensive audit reports, including findings, recommendations, action plans, schedules, and summaries.

• Lead root cause analyses, conduct interviews, and document investigations.

• Suggest and oversee corrective and preventative actions through the design and implementation of CAPA.

• Manage audit logistics and deliverables, including both remote and onsite audits.

• Ensure audits are conducted within budget and according to established plans.

• Facilitate post-audit debriefings and communicate findings to relevant stakeholders.

• Encourage continuous improvement of Quality/GxP auditing services.

• Maintain a comprehensive understanding of regulatory requirements and ICH guidelines.

• Develop and enhance audit processes and procedures.

• Provide coaching and training on quality-related topics and audit performance.

• Manage both paper and electronic systems for supplier qualification processes.

• Present quality metrics to the Quality team.

• Execute other administrative and managerial tasks as needed.

⛳️ Requirements

• A minimum of a bachelor’s degree in any scientific discipline (as detailed under Preferred Qualifications).

• 5–7 years of experience in the biopharmaceutical industry.

• At least 3 years of GxP auditing experience in a regulated quality environment, with a preference for CGT.

• Strong knowledge of GxP regulatory requirements.

• Experience with electronic Quality Management Systems.

• Auditor certification is preferred.

• Ability to juggle multiple projects in a fast-paced environment.

• Proficiency in collaborating effectively within a dynamic, cross-functional matrix environment.

• Capability to identify when issues need to be escalated to Senior Quality Management.

• Detail-oriented with precise and organized document handling.

• Strong organizational skills with the ability to prioritize numerous tasks.

• Familiarity with ICH guidance and relevant internal, external, and industry best practices.

• Willingness to travel 50% of the time (application question).

• Must be authorized to work in the United States; the posting inquires about the need for future visa sponsorship.

🏝️ Benefits

• Competitive benefits package.

• Paid Time Off (PTO).

• Stock option plans.

• Commitment to employee well-being and ongoing development.

• Recognized as a Great Place to Work-Certified company.