Global Head of Quality Audit, External Liaison

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Create, develop, and execute the strategic roadmap for the department.

• Direct risk-focused auditing strategies, tactics, and operations across GXP.

• Engage with external partners for intelligence gathering, benchmarking, and advocacy on key Sanofi issues.

• Oversee regulatory inspection processes for both routine and pre-approval inspections conducted by international regulators.

• Assist in due diligence and reverse due diligence efforts.

• Leverage data and technology to enhance efficiencies, improve insights, encourage knowledge sharing, and streamline processes.

• Represent Sanofi at significant industry and trade association meetings and working groups.

• Promote a culture of quality and cGMP compliance throughout all organizational levels to drive ongoing improvement.

• Function with a high degree of independence, exercise thoughtful risk-taking, and maintain a compliance-oriented mindset.

• Collaborate with Auditing and Compliance teams across Sanofi.

⛳️ Requirements

• A minimum of 15 years of relevant experience in the pharmaceutical, biotech, medical device, or related sectors, or with a major regulatory authority.

• Extensive experience with regulatory matters and pharmaceutical policy.

• Proven track record in inclusive, transformative leadership and change management.

• Proficiency in English is required.

• A Bachelor's degree in a relevant scientific field is mandatory.

• Experience as an auditor, interfacing with regulatory authorities, and/or in regulation intelligence or advocacy is advantageous.

• Ability to speak French is a plus.

🏝️ Benefits

• Opportunities for advancement or lateral career transitions, both domestically and internationally.

• Comprehensive rewards package.

• Health and wellness benefits.

• Access to high-quality healthcare services.

• Programs focused on prevention and wellness.

• At least 14 weeks of gender-neutral parental leave.

• An innovative environment driven by cutting-edge technology, digital advancements, data, and AI.