Vice President, Head of Quality

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 alongside them 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 impact—and making history.We all share the most important goal of bringing solutions to the PWS community. 

Summary of Job (brief description)

 The VP, Head of Quality reports to Soleno’s Chief Executive Officer and will be responsible for leading and developing the quality function, in line with the company stage, and ensuring global regulatory, industry, and corporate standards are met. This leader will balance strategic vision with hands-on execution, working closely with Regulatory, Clinical, Operations, Clinical Development and Supply Chain teams, as well as external suppliers, manufacturing and testing partners. 

Responsibilities

• Lead and evolve the Quality function including Quality Assurance, Quality Control, Clinical Quality and Supplier Quality.
• Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment.
• Oversee all GxP activities in alignment with business objectives and applicable regulatory requirements across all programs and functional activities.
• Oversee commercial product release for global markets, ensuring compliance with cGMP, GDP, and local regulatory requirements.
• Lead a team of quality professionals, including objective setting, performance management, coaching, training/mentoring, development, and recruiting.
• Proactively identify issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are in place.
• Provide QA oversight for product lifecycle activities, including post-approval changes, label updates, and global regulatory submissions.
• Drive Quality decisions, approvals and guidance. Maintain a strong independent role in that regard.
• Accountable for compliant Health Authority inspections outcome and commitment to meet expected alignment.
• Ensure a state of inspection readiness and represent Soleno Therapeutics as host of regulatory inspections internally and at applicable contract sites involved in GxP activities.
• Ensure ongoing process validation, stability programs, continued process verification for commercial products.
• Lead the continuous improvement of the Quality Management System. Act as a champion for building a “culture of quality” across the organization.
• Foster an environment of collaboration, trust, quality, risk management, innovation and continuous improvement within Soleno Therapeutics.

Qualifications

• 15+ years of professional quality experience in a biotechnology/pharmaceutical setting, as well as experience in small molecules in both clinical development and commercial manufacturing .
• Prior management of commercial quality systems including change management, risk management, supplier management, deviations/CAPA management review and product complaints. • Proven track record of successfully leading quality through a commercial launch and subsequent product lifecycle.
• Strong knowledge with both the US and international regulations and guidance, including GxPs and industry trends.
• Experience managing external partners (CMOs, CTLs, distributors) in a lean biotech environment. • Ability to balance multiple priorities and complex issues using logical, analytical, and efficient processes with a high level of attention to detail and quality of work.
• Ability to develop new business relationships and maintain partnerships with internal and external stakeholders. Additionally, have the ability to provide cross-functional team leadership to maintain alignment and to set and meet collective operational goals.
• Strong leadership skills with the ability to operate strategically and roll up sleeves when necessary.
• Excellent oral and written communication skills and can facilitate/articulate recommendations and critical decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across the company with strong technical writing experience are required.
• A strong GMP background in DS/DP quality is a plus .
• Ability to travel ~25%.

Salary Range: $290K - $320K

(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 candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)