Neuralink Corp.
Internal Audit Lead
Neuralink Corp., Fremont, California, us, 94537
Team Description:
Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.
Job Responsibilities and Description:
Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and Neuralink policies
Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed
Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action
Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions
Lead the front room for external audits (i.e., FDA or other notified bodies)
Required Qualifications:
Bachelor's degree in a relevant scientific or healthcare field
4+ years of experience as an auditor
Experience being in the front room for external audits (FDA or other notified bodies)
Experience conducting audits of GLP, GMP, and GCP
Working knowledge of FDA regulatory requirements and standards
Strong quality assurance and analytical skills
Excellent communication and collaboration abilities
Experience with regulatory and technical writing
Preferred Qualifications:
Engineering background
Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP)
Experience with supplier audits
Experience leading an internal audit program
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Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.
Job Responsibilities and Description:
Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and Neuralink policies
Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed
Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action
Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions
Lead the front room for external audits (i.e., FDA or other notified bodies)
Required Qualifications:
Bachelor's degree in a relevant scientific or healthcare field
4+ years of experience as an auditor
Experience being in the front room for external audits (FDA or other notified bodies)
Experience conducting audits of GLP, GMP, and GCP
Working knowledge of FDA regulatory requirements and standards
Strong quality assurance and analytical skills
Excellent communication and collaboration abilities
Experience with regulatory and technical writing
Preferred Qualifications:
Engineering background
Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP)
Experience with supplier audits
Experience leading an internal audit program
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