Manager, Clinical Quality Assurance

Description

Your Impact:

You will be an integral part of the Poseida Quality organization that is dedicated, agile, and collaborative. In this role, you will work on-site directly with Poseida Research and Development functions as well as the Clinical teams including Clinical Development, Clinical Operations, Translational Medicine. Your talents and expertise will directly contribute to Poseida’s passion - developing innovative therapies with the capacity to cure. You will learn and advance in your career as this group is forward-thinking and fully supportive of career development. If you are an individual that is driven to make a difference, have a strong work ethic, and you want to be a part of an exciting bigger picture, the Poseida Quality team welcomes you!

Position Summary:

Poseida Therapeutics, Inc. is seeking an exceptional candidate to join our Quality team in San Diego, CA. The Manager, Clinical Quality candidate will have a strong Quality background to support related responsibilities to support our clinical development programs across the Poseida portfolio of products. The successful candidate will provide Quality support to ensure adherence with Company Quality Policies/procedures. 

Responsibilities:

Clinical Quality functions include but are not limited to:

• Work in partnership with Clinical and R&D functional groups to facilitate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessary
• Provide quality management oversight and facilitation of quality event management at CRO’s for assigned clinical programs and/or studies, including assessment of potential root causes and CAPA
• Support and lead cross-functional clinical teams and provide guidance related to GLP/GCP requirements based on interpretation of current regulations and through the application of Poseida procedures to ensure best practices and compliance
• Participate and lead GCP audits (e.g. clinical site audits, vendors, internal systems), in support of the clinical programs
• Facilitate and support the selection and qualification of third party vendors, contract laboratory facilities and contractors, in partnership with R&D and Clinical teams
• Manage the Clinical audit program by scheduling audits, conducting pre-audit meetings, drafting audit plans, agendas, audit reports, and executing the audit program.
• Provide quality review of internal procedures, clinical protocols, investigators brochure, clinical study reports and other relevant study documents as needed
• Clinical QA leadership for inspection readiness and manage the internal audit program
• Report GCP quality metrics to ensure that quality standards are maintained across the clinical programs
• Work closely with Clinical and Quality management to ensure compliance to regulations, guidelines and company SOPs.
• Identify opportunities for improvement within the assigned roles and responsibilities and take initiative to drive the change
• Complete other Quality based activities as assigned
• Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority
• Fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product

Requirements

Requirements, Knowledge, Skills, and Abilities:

• Bachelor’s or Master’s degree in life sciences or a related field with 8+ years of relevant experience in a Clinical QA role. (An equivalent combination of education and experience may be considered.) Knowledge of clinical trial systems and processes.
• Prior direct experience in Good Clinical Practice (GCP) required with proficiency/ knowledge of ICH, GCP, and applicable CFRs, guidance documents, systems processes, and procedures 
• Prior experience in working with Clinical Research Organizations and contracted central laboratories
• Strong attention to detail and respect for the need of accuracy of information
• Must be capable and willing to travel (approx.25%) 
• Must have a thorough understanding of applicable US and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits
• Detail oriented with excellent written and verbal communication skills
• Intermediate to advanced computer skills in Excel, PowerPoint, and word processing
• Ability to effectively work independently, within prescribed guidelines, and as a team member
• Demonstrated ability to work efficiently in a dynamic, complex, and fast-paced team environment

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