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Soleno Therapeutics, Inc. · 3 months ago

Vice President, Head of Quality

Redwood City, CA

Full-time

Onsite

Director/Executive

$290K/yr - $320K/yr

15+ years exp

Soleno Therapeutics, Inc. is a biopharmaceutical company focused on developing therapeutics for rare diseases. The VP, Head of Quality will lead and develop the quality function, ensuring compliance with global regulatory standards while working closely with various teams and external partners.

BiotechnologyMedicalPharmaceutical

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

Qualification

Quality AssuranceQuality ControlGxP ComplianceBiotechnology ExperienceRisk ManagementSupplier ManagementLeadership SkillsAnalytical SkillsCommunication SkillsCollaboration

Required

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%