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Executive Director, GCP Quality Assurance

Company: Sorrento Therapeutics
Location: San Diego
Posted on: May 16, 2022

Job Description:

Job DescriptionSalary: DOE+Benefits+OptionsABOUT US Sorrento Therapeutics, Inc. is a clinical stage and commercial biopharmaceutical company focused on delivering innovative and clinically meaningful therapies to address unmet medical needs. Our vision is to leverage our proprietary G-MAB™ library in conjunction with proprietary targeted delivery modalities to generate the next generation of therapeutics for treating cancer, autoimmune, inflammatory, viral and neurodegenerative diseases. These modalities include proprietary chimeric antigen receptor T-cell therapy (CAR-T), dimeric antigen receptor T-cell therapy (DAR-T™), antibody drug conjugates (ADCs), oncolytic virus (Seprehvec™), lymphatic drug targeting (SOFUSA®), as well as bispecific antibody approaches. We are additionally developing pain management solutions, including our clinical candidates resiniferatoxin (RTX) and SEMDEXA™. In response to the global SARS-CoV-2 ("COVID-19") pandemic, we are also developing and conducting clinical studies for potential coronavirus antiviral therapies and vaccines, including Abivertinib, COVI-MSC™, COVI-AMG™, COVIDROPS™, and COVI SHIELD™, and diagnostic test solutions, such as COVISTIX™ and COVITRACK™. We attract smart people who play well with others. We're small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career. If you're a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you! Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations and guidance from the Safer Federal Workforce Task Force, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force's 2021 Guidance for Federal Contractors and Subcontractors (Updated November 10, 2021), available at: WHAT WE ARE LOOKING FOR: Sorrento Therapeutics ("Sorrento") is seeking an experienced Executive Director, GCP Quality Assurance to join our team. WHAT YOU'LL DO: The Executive Director, GCP Quality Assurance is responsible for establishing the vision and implementing the associated strategy for the Quality Assurance functions for GCP clinical operations. This responsibility includes the development, execution and maintenance of risk-based audit strategies focused on internal and external GCP audits to ensure that clinical trials are in compliance with applicable regulations, ICH GMP guidelines, and Sorrento Therapeutics procedures. The Executive Director, GCP QA is also responsible for deploying comprehensive GCP inspection readiness plans. Moreover, the Executive Director GCP QA is responsible for the development, maintenance and continuous improvement of departmental processes and procedures and support of the implementation and continuous improvement of Quality systems. This position fosters and promotes a GCP compliant environment with internal and external stakeholders. ESSENTIAL DUTIES AND RESPONSIBILITIES:This function is the internal GCP expert within Quality Assurance. Roles and Responsibilities:

  • Establish the vision and implement the associated strategy for the Clinical Quality Assurance function within Sorrento Therapeutics.
  • Manage and/or participate in complex audits, including but not limited to, internal process, external vendors; determine compliance status and identify compliance risks.
  • Institute comprehensive GCP inspection readiness plans for regulatory authority inspections of Sorrento Therapeutics. Conduct the GCP inspections. Direct the development of adequate and appropriate responses and resolutions to identified observations. Drive timely completion of the agreed corrective and preventive actions.
  • Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, always acting with an appropriate sense of urgency.
  • Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends, and driving improvements thus identified.
  • Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.
  • Perform detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
  • Oversee company-wide required annual GCP training.
  • Continuously remain up to date with the latest industry changes with regulatory requirements, industry standards and provide consultancy on quality/ compliance/ regulatory related issues.
  • Represent GCP Quality Assurance on compliance-related projects and initiatives.
  • Where assigned, lead such projects and initiatives, particularly those related to application of new and revised industry standards, guidelines and regulations within all affiliated areas.
  • Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
  • Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
  • Establish goals for the Quality Assurance department and ensure those goals are achieved.
  • Supervise, support and train staff in the execution of their functions ensuring audits and inspections are executed successfully, performance goals are met and development needs are identified and supported.
  • Effectively manage staff wherever they may be seated.
  • Participate in the development and management of the departmental budget.
  • Perform other duties as assigned. Skills/Knowledge Required:
    • In-depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures.
    • Demonstrated ability to define and implement procedures which ensure compliance to GCP and regulatory standards.
    • Extensive experience in and knowledge of internal and external GCP auditing and quality systems operations.
    • Wide-ranging experience leading regulatory authority inspections of manufacturing facilities, particularly in the US and EU, but also in Rest of World regions.
    • Proficient hands-on experience managing quality and compliance-related projects and programs.
    • Proven ability in driving GCP process improvement initiatives.
    • Balanced approach to issue management and risk mitigation planning.
    • Consistently and confidently exercise independent, sound judgment in making decisions.
    • Current and in-depth knowledge and application of international requirements of Good Clinical Practice (GCP), ICH GCP Guidelines, regulations and compliance initiatives globally applicable to the conduct of clinical trials.
    • Strong knowledge of health authority submission activities, specifically in relation to Quality, for regulatory filings in USA, EU and Rest of World regions.
    • Exemplary cross-functional partnering and collaboration skills.
    • Demonstrated exceptional engagement and Interpersonal skills.
    • Ability to translate technical knowledge into guidance that is appropriate for audiences with differing degrees of experience.
    • Ability to manage multiple projects in a demanding fast-paced environment.
    • Excellent oral and written communication skills for effectively interfacing with other departments within the company, vendors, investigator sites, health authorities and others.
    • Highly detail oriented with critical document/ process/ procedure/ system review competencies.
    • Outstanding leadership experience and mentoring skills to ensure team members have the coaching and mentoring necessary to be successful.
    • Skilled at budgetary management.
    • Superior computer literacy in MS Word, Excel, and PowerPoint. EDUCATION AND QUALIFICATIONS:
      • Executive Director should have a minimum of 20 years relevant experience, or equivalent, with increasingly responsible in the Biotech/ Pharmaceutical Industry, specifically within GCP functions.
      • Extensive experience in GCP auditing and managing regulatory authority inspections is required.
      • Bachelor's or master's degree in a scientific or life sciences discipline. A healthcare background is preferred. YOUR REWARD:
        • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
        • Earn a competitive salary that allows you to focus your attention on your passion.
        • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, company paid holidays, and Flexible PTO, plus equity-based compensation. If this sounds like the right career to fit your personality and interests, please apply, we're looking forward to meeting you! Principals only. Recruiters, please do not contact this job poster. Sorrento Therapeutics, Inc. is an Equal Opportunity Employer.

Keywords: Sorrento Therapeutics, San Diego , Executive Director, GCP Quality Assurance, Executive , San Diego, California

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