Sr Quality Assurance Specialist / Manager

Company: Soleno Therapeutics Inc
Location: Redwood City
Posted on: October 7, 2024

Job Description:

Sr Quality Assurance Specialist / ManagerAbout Soleno Therapeutics IncSoleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).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 most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.Summary of JobWe are seeking a highly motivated individual to join Soleno Therapeutics who will play a key role within Quality Assurance for operational support. Responsibilities will primarily include the support of Soleno's CMOs/CTLs covering manufacturing operations and QC activities. The position will also assist in other quality and compliance activities, including, but not limited to, deviations, CAPAs, change control, supplier quality, audit management, and inspection readiness.Responsibilities

• Support QA oversight of the manufacture and disposition of clinical and commercial product, DS, DP, and FP at CMOs in partnership with CMC, Supply Chain, and QC.
• Perform the review, approval, and disposition of DS and packaged/labeled drug product, including review of executed batch records, specifications, certificate of analysis, for manufacturing and testing performed by CMOs/CTLs.
• Collaborate with internal and external stakeholders on quality systems activities such as deviations, CAPAs, change controls, and document revisions.
• Collaborate with QC and Analytical Development to provide quality oversight for GMP activities including approval of method validation, specifications, release testing, and stability for drug substance and drug product.
• Support clinical and commercial QA activities including product complaints, APQRs, and quality metric reviews.
• Participate in developing and improving Standard Operating Procedures to ensure quality objectives are met.
• Participate in inspection readiness efforts.
• May work on assignments and other duties to support Quality Operations where judgment is required in resolving problems and making recommendations.Qualifications
• Bachelor's Degree in a scientific discipline.
• Minimum of 7 years of relevant experience in Quality Assurance in the pharmaceutical/biotech industry or equivalent combination.
• Experience managing quality aspects of manufacturing and testing activities as CMOs.
• Strong analytical skills and a strong technical background in small molecule process, oral solid dosage, manufacturing is desired.
• Demonstrates proficiency in Microsoft Office suite (e.g., Word, Excel).
• Knowledgeable of current regulatory guidance, including GxPs.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Responsible and self-motivated with effective time management, organizational, and planning skills.Salary Range: $90,000-$145,000(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 candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.)
  #J-18808-Ljbffr

Keywords: Soleno Therapeutics Inc, Dublin , Sr Quality Assurance Specialist / Manager, Executive , Redwood City, California