Job Description

Senior Manager/Associate Director Supplier Quality and Compliance

About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are it is in our chromosomes and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongsidethem every step of the way.

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impactand making history. We all share the most important goal of bringing solutions to the PWS community.

Summary of Job (brief description)

We are seeking a highly motivated individual to join Soleno Therapeutics supporting Quality Systems. Responsibilities primarily include the oversight of Solenos 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

• Bachelors 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 Range: $170,000 - $220,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidates relevant qualifications, skills, and experience, as well as the location where this position may be filled.)

#J-18808-Ljbffr

Job Tags

Similar Jobs