Manager, Quality Assurance Operations

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  "last_changed_at": "2026-05-29T07:01:33.483Z",
  "active_status": "active"
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{
  "language": "en",
  "location": {
    "raw": "Northwest, Indiana",
    "city": "Northwest",
    "region": "IN",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.85
  },
  "salary_max": null,
  "salary_min": null,
  "inferred_at": "2026-06-06T07:55:57.370Z",
  "launch_scope": {
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    "included": true,
    "language": "en",
    "location": {
      "raw": "Northwest, Indiana",
      "city": "Northwest",
      "region": "IN",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.85
    },
    "countries": [
      "United States"
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  "remote_policy": null,
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  "workplace_type": "on_site",
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{
  "lists": [
    {
      "text": "PRIMARY RESPONSIBILITIES",
      "content": "<li>Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of drug product to be used in clinical studies</li><li>Supporting the development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelines</li><li>Supporting the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/maintenance for the facility</li><li>Supporting day-to-day QA activities associated with manufacturing of drug product</li><li>Releasing manufacturing suites and batch/product changeovers for continuation of manufacturing activities</li><li>Participating in cross-functional teams to resolve quality-related issues impacting manufacturing activities</li><li>Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facility</li><li>Evaluating and approving proposed process changes and improvements in the manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines</li><li>Supporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicable</li><li>Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.)</li><li>Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as needed</li><li>Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility</li><li>Maintaining the QA Operations function in a state of compliance and inspection readiness</li>"
    },
    {
      "text": "BASIC QUALIFICATIONS",
      "content": "<li>B.S./M.S. in Life Sciences or related field with 5+ years of experience, including leadership, in GMP Quality Assurance</li><li>Experience with QA and GMP compliance in clinical biologics products</li><li>Experience providing QA oversight to manufacturing operations in a pharmaceutical/ biotechnology environment</li><li>Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures</li><li>Experience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations</li><li>Ability to organize and prioritize workload to meet deadlines and company objectives.</li><li>Ability to work independently and within cross-functional teams</li><li>Knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics</li>"
    },
    {
      "text": "LEADERSHIP QUALIFICATIONS",
      "content": "<li>Organizational, staff mentorship, and time management skills with attention to details</li><li>Handling multiple assignments in a fast-paced environment with changing priorities</li><li>Independent development and execution of work plans with minimal supervision</li><li>Strong analytical problem-solving, and critical thinking skills</li><li>Excellent written and verbal communication skills with the ability to communicate effectively</li>"
    }
  ],
  "country": "US",
  "createdAt": 1770149561966,
  "updatedAt": null,
  "categories": {
    "team": "Quality",
    "location": "Northwest, Indiana",
    "commitment": "Full-Time",
    "allLocations": [
      "Northwest, Indiana"
    ]
  },
  "salaryRange": null,
  "workplaceType": "onsite"
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