Senior Manager/Associate Director Supplier Quality and Compliance

Role Summary

We are seeking a highly motivated individual to join Soleno Therapeutics supporting Quality Systems. Responsibilities primarily include the oversight of Soleno’s GxP Vendor Management and Inspection Readiness Programs.

Responsibilities

• Lead the GxP Vendor Management Program:
• Coordinate audits of external vendors and internal audits to ensure compliance to applicable global regulations and standards.
• Utilize compliance risk assessments to develop internal and external audit schedules.
• Develops and reviews audit agendas, audit reports, audit findings and responses.
• May conduct audits of external vendors as needed.
• Lead inspection readiness activities and assist with hosting onsite inspections.
• Provides cross-functional guidance to compliance-related issues.
• Assist with Quality Systems (Quality Agreements, Deviation, Change Control, CAPA, Management Review and Metrics) as needed.
• May work on assignments and other duties to support Quality Systems where judgement is required in resolving problems and making recommendations.
• Keep abreast of current regulatory regulations and guidelines.

Qualifications

• Bachelor’s Degree in a scientific discipline.
• 10+ years of experience in Quality Assurance with direct experience leading pharmaceutical supplier quality and/or GxP compliance programs.
• Interaction with regulatory inspectors preferred.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
• Experience working with third party external manufacturers and suppliers.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Responsible and self-motivated with effective time management, organizational, and planning skills.
• Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures.

Salary

$170,000 - $220,000