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Executive Director Quality Systems & Compliance

Company: Aspen Neuroscience, Inc.
Location: San Diego
Posted on: November 22, 2021

Job Description:

Aspen is looking for strong leadership and quality expertise in this new role reporting to the Senior Vice President Regulatory. The Executive Director, Quality Systems and Compliance, will lead all aspects of the company's quality organization including Quality Systems and Compliance, Quality Engineering, Quality Control, Quality Operations and GCP. This is a unique opportunity to build a team in a culture where employees are respected and rewarded for hard work, innovation, personal initiative, and collaboration.
Responsibilities include:

  • Represents all Quality functions on the Technical Operations Leadership Team
  • Ensures GMP compliance while building teams and developing people to create a culture of quality excellence.
  • Directs and oversees Quality Systems and Compliance including technical training, document control, compliance, inspection readiness, quality systems, quality management reviews, supplier quality and internal/external audits.
  • Collaborates closely with F&E (Facilities and Equipment), IT and manufacturing, to build and maintain a robust Quality Engineering organization responsible for CQV (commissioning, qualification, and validation), risk assessments, data integrity and computer system validation.
  • Accountable for all aspects of Quality Control including analytical, specifications, sample management, stability, LIMS, raw material testing and support technical regulatory submissions.
  • Responsible for the strategic development and deployment of Aspen's quality operating model including quality sub-functions and their capabilities.
  • Build and deploy a team that delivers material testing, environmental monitoring, methods and supports facility qualification and validation.
  • Working closely with manufacturing and process development, leads a Quality Operations group that supports deviation resolution, CAPA, MBR review.
  • Oversees a team who are responsible for clinical sites / CRO vendor audits.
  • Drives continuous improvement through effective organizational management, budgeting, reporting, project management and operational excellence within the function. Education and Experience:
    • Degree in the biological sciences; PhD or MS preferred.
    • 15+ years of technical experience in GMP pharmaceutical or biologics manufacturing environment. Cell Therapy experience is preferred.
    • Experience in both QC and QA is preferred.
    • 10+ years of experience in a leadership Quality management role is required.
    • Exceptional understanding of fundamental quality concepts including aseptic manufacturing, process validation and control and technology transfer.
    • Demonstrated ability to successfully interact with health authorities at regulatory meetings and inspections.
    • Demonstrated ability to act as change agent and make objective, inclusive, robust an unbiased decision with imperfect information
    • 8 years of experience in the pharmaceutical or biotechnology industry and 4 years of experience in conducting internal and external audits
    • Experience managing the QA & QC function
    • Certified Quality Auditor (CQA) certification preferred
      Job Specifications
      • Knowledge of regulations and standards affecting Pharmaceuticals, and Biologics.
      • Knowledge and application of GMP/GCP/ICH standards and regulatory guidance documents
      • Strong capabilities in auditing and writing formal audit reports
      • Strong understanding of cGMP, GLP, GCP and GvP compliance requirements associated with US, EU, ICH and other pertinent regulatory agencies.
      • Strong listening skills and exceptional written and verbal communication abilities.
      • Visionary thinker with a desire to excel and inspire others
      • Self-reliant, passionate, enthusiastic with a focus on driving results
      • Structured and well organized
      • Able to travel 25% of the time
        Total Rewards and Culture Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.
        EEO and Employment Eligibility Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. To apply: Please email your resume to

Keywords: Aspen Neuroscience, Inc., San Diego , Executive Director Quality Systems & Compliance, Executive , San Diego, California

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