Director, Quality Assurance & Quality Systems

{
  "content_hash": "dfcaa6ebe9f1a316aa8992678d107cb499cc2a6bebc72295e5c099a6c4026085",
  "source_hash": "fa06d964f897a4f1e2921fbb74930584a462d002b5d78307d0f47c0cd99d32a3",
  "last_changed_at": "2026-05-30T07:36:11.049Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "San Diego, CA",
    "city": "San Diego",
    "region": "CA",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.9
  },
  "salary_max": 215000,
  "salary_min": 175000,
  "inferred_at": "2026-06-06T19:46:29.748Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "San Diego, CA",
      "city": "San Diego",
      "region": "CA",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.9
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": null,
  "salary_period": "year",
  "workplace_type": "on_site",
  "salary_currency": "USD"
}

{}

{
  "lists": [
    {
      "text": "Responsibilities",
      "content": "<div>\n<p><span style=\"text-decoration: underline;\"><strong>Quality Assurance &amp; Quality Systems Leadership&nbsp;</strong></span></p>\n\n<li>Lead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standards&nbsp;</li>\n<li>Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodies&nbsp;</li>\n<li>Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS)&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Quality Systems Management&nbsp;</strong></span></p>\n\n<li>Oversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocols&nbsp;</li>\n<li>Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements&nbsp;</li>\n<li>Establish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectiveness&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Compliance &amp; Regulatory&nbsp;</strong></span></p>\n\n<li>Establish and enforce quality assurance policies and procedures across all operational departments&nbsp;</li>\n<li>Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements&nbsp;</li>\n<li>Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions)&nbsp;</li>\n<li>Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Cross-Functional Collaboration &amp; Lifecycle Management&nbsp;</strong></span></p>\n\n<li>Collaborate with cross-functional teams (R&amp;D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle&nbsp;</li>\n<li>Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA)&nbsp;</li>\n<li>Support technology transfer activities and new product introductions from a quality systems perspective&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Continuous Improvement &amp; Risk Management&nbsp;</strong></span></p>\n\n<li>Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency&nbsp;</li>\n<li>Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles&nbsp;</li>\n<li>Champion a culture of quality throughout the organization&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Performance Management &amp; Reporting&nbsp;</strong></span></p>\n\n<li>Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors&nbsp;</li>\n<li>Mentor and develop QA/QS staff, fostering a culture of accountability, compliance, and continuous professional growth&nbsp;</li>\n\n</div>"
    },
    {
      "text": "Requirements",
      "content": "<div>\n<p><span style=\"text-decoration: underline;\"><strong>Education &amp; Experience&nbsp;</strong></span></p>\n\n<li>Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred)&nbsp;</li>\n<li>10+ years of progressive experience in Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices)&nbsp;</li>\n<li>Direct experience in cell and gene therapy or advanced therapeutic products is highly desirable&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Technical Knowledge&nbsp;</strong></span></p>\n\n<li>Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271&nbsp;</li>\n<li>Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance&nbsp;</li>\n<li>Proven experience with electronic quality systems (eQMS) platforms (e.g., Veeva, MasterControl, TrackWise, or similar)&nbsp;</li>\n<li>Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.)&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Leadership &amp; Management&nbsp;</strong></span></p>\n\n<li>Proven experience leading quality assurance and quality systems teams and managing cross-functional collaborations&nbsp;</li>\n<li>Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments&nbsp;</li>\n<li>Experience managing regulatory inspections and audit readiness programs&nbsp;</li>\n\n<p><span style=\"text-decoration: underline;\"><strong>Skills &amp; Competencies&nbsp;</strong></span></p>\n\n<li>Excellent problem-solving, analytical, and decision-making skills&nbsp;</li>\n<li>Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders&nbsp;</li>\n<li>Experience in preparing and presenting reports and metrics to senior management and board members&nbsp;</li>\n<li>Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence&nbsp;</li>\n<li>Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities&nbsp;</li>\n\n</div>"
    },
    {
      "text": "Work Environment / Physical Demands",
      "content": "<div>\n\n<li>Primarily office-based with required time in GMP spaces addressing quality management and audits.&nbsp;</li>\n<li>Requires prolonged periods of computer use for documentation, data analysis, and report generation related to quality processes.&nbsp;</li>\n<li>May involve lifting office materials or equipment up to 10 pounds.&nbsp;</li>\n<li>Ability to navigate office and GMP environments for audits and oversight.&nbsp;</li>\n\n</div>"
    }
  ],
  "country": "US",
  "createdAt": 1777588527013,
  "updatedAt": null,
  "categories": {
    "team": "Quality Assurance",
    "location": "San Diego, CA",
    "commitment": "Full-time (exempt)",
    "department": "Capricor Therapeutics",
    "allLocations": [
      "San Diego, CA"
    ]
  },
  "salaryRange": {
    "max": 215000,
    "min": 175000,
    "currency": "USD",
    "interval": "per-year-salary"
  },
  "workplaceType": "onsite"
}