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DIRECTOR OF QUALITY

Fbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003 · Irvine, CA, US, Irvine, CA · Active · $135,000–$160,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
CompanyFbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003
TitleDIRECTOR OF QUALITY
Normalized title-
Department / team-
LocationIrvine, CA, United States
Work model-
Employment typeFull Time
Salary$135,000–$160,000 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-03-23 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Irvine.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyFbb6193d 556c 4b29 98e5 7306aa3f6384 19000101 000003
Sourcee088055a-0c65-47db-aa4c-74f9b0047486
ATS providerADP Workforce Now Recruiting

Description

We have an open position for a Director of Quality located in Irvine, California facility to oversee the Quality Department for MainPointe Pharmaceuticals, LLC. RESPONSIBILITIES: Oversight of Quality Systems at the facility ensuring all products produced consistently meet quality specifications. Plans and directs resources and activities of the Quality Assurance functions and assures that facility-wide activities are performed and maintained in compliance with the appropriate standards and regulations. Manages systems for raw materials, product and document review, approval, or rejections. Oversight of Quality Control laboratory Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the facility. Assures facility and equipment systems meet cGMP requirements. Oversee investigations of all non-conformances (deviations, OOS) and chair’s site Material Review Boards. Establishment of raw material and finished product specifications based on regulatory requirements and customer needs and in conjunction with product development and other site quality departments. Author and/or approve standard operating procedures, protocols, qualifications, and quality reports. Manages customer complaint and AER systems and associated investigations, resolution and CAPA’s. Assure all employees are trained in cGMP. Actively participate in production, quality unit, and management meetings as needed. Development and maintenance of appropriate tracking methods for quality process improvements. Coordinate and manage vendor audits. Manage Annual Product Review (APR) program and assure Product Quality Reports are completed on a timely basis. Manages the Quality Key Performance Indicator data collection and reporting in support of Management Review. Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the facility maintains a state of readiness for inspection by regulatory agencies. Serves as an interface for inspections by FDA, DEA, and other regulatory agencies and customers. Support oversight of document control systems. Use of statistical process control to evaluate trends. Development and maintenance of appropriate quality agreements with customers. Budgetary and managerial responsibility for Quality Assurance and Quality Control departments at facility. QUALIFICATIONS: Bachelor’s degree in scientific discipline 12+ years’ related experience in a Pharmaceutical GMP regulated manufacturing environment, with a demonstrated history of progressive growth and advancement required 5+ years of management experience; or equivalent combination of education and experience Strong commitment to quality standards with leadership and management skills. Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations. Strong communication skills, both written and verbal. Possess positive qualities of effective leadership, staff motivation and conflict resolution. Strong attention to detail and ability to multitask. ASQC quality certifications, ISO 9000 or other Audit training preferred. At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.

Full job record

Job IDff182f1849c009af07e9e899dddf2e241cb8b5cc
Org ID1c12f03c-6518-4018-9e8a-db5c3c140f34
Source IDe088055a-0c65-47db-aa4c-74f9b0047486
Board IDe088055a-0c65-47db-aa4c-74f9b0047486
Provideradp_workforcenow
Provider Job Key515459
TitleDIRECTOR OF QUALITY
Normalized Title—
Statusactive
Activeyes
Location TextIrvine, CA, US, Irvine, CA
Department—
Team—
Employment Typefull_time
Workplace Type—
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CountryUnited States
RegionCA
CityIrvine
Salary Raw135000.00 To 160000.00 (USD) Annually
Salary Min135,000
Salary Max160,000
Salary CurrencyUSD
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First Seen At2026-05-31 18:58:01Z
Last Seen At2026-06-06 12:58:45Z
Last Checked At2026-06-06 12:58:45Z
Last Changed At2026-06-06 12:58:45Z
Inactive At—
Source Posted At2026-03-23 17:31:00Z
Source Updated At—
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Event Fields
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Extensions
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    "requisitionDescription": "<div><div><div><h2 style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><br></h2><p><span style=\"font-family: arial, sans-serif; font-size: 18px;\">We have an open position for a Director of Quality located in Irvine, California facility to oversee the Quality Department for MainPointe Pharmaceuticals, LLC.&nbsp;&nbsp;</span></p><p><br></p><p><span style=\"font-size:15px;\">RESPONSIBILITIES:</span></p><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><br></p><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: -0.3in;\"><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Oversight of Quality Systems at the facility ensuring all products produced consistently meet quality specifications.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Plans and directs resources and activities of the Quality Assurance functions and assures that facility-wide activities are performed and maintained in compliance with the appropriate standards and regulations.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Manages systems for raw materials, product and document review, approval, or rejections.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Oversight of Quality Control laboratory</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the facility.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Assures facility and equipment systems meet cGMP requirements.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Oversee investigations of all non-conformances (deviations, OOS) and chair&rsquo;s site Material Review Boards.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Establishment of raw material and finished product specifications based on regulatory requirements and customer needs and in conjunction with product development and other site quality departments.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Author and/or approve standard operating procedures, protocols, qualifications, and quality reports.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Manages customer complaint and AER systems and associated investigations, resolution and CAPA&rsquo;s.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Assure all employees are trained in cGMP.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Actively participate in production, quality unit, and management meetings as needed.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Development and maintenance of appropriate tracking methods for quality process improvements.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Coordinate and manage vendor audits.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Manage Annual Product Review (APR) program and assure Product Quality Reports are completed on a timely basis.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Manages the Quality Key Performance Indicator data collection and reporting in support of Management Review.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Work across all disciplines (e.g. manufacturing, clinical, R&amp;D, etc.) to ensure that the facility maintains a state of readiness for inspection by regulatory agencies.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Serves as an interface for inspections by FDA, DEA, and other regulatory agencies and customers.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Support oversight of document control systems.&nbsp;</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Use of statistical process control to evaluate trends.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Development and maintenance of appropriate quality agreements with customers.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style='font-family:\"Times New Roman\",serif;font-size:15px;'>Budgetary and managerial responsibility for Quality Assurance and Quality Control departments at facility.</span></li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;text-align:justify;font-size:13px;font-family:\"Arial\",sans-serif;'><br></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;text-align:justify;font-size:13px;font-family:\"Arial\",sans-serif;'><br></p><p><strong><span style='font-size:15px;font-family:\"Times New Roman\",serif;'> </span></strong><strong><span style=\"font-size:15px;\">QUALIFICATIONS:</span></strong></p><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><strong>&nbsp;</strong></p><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: -0.25in;\"><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Bachelor&rsquo;s degree in scientific discipline</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">12+ years&rsquo; related experience in a <strong>Pharmaceutical GMP regulated manufacturing environment,&nbsp;</strong>with a demonstrated history of progressive growth and advancement required</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\">5+ years of management experience; or equivalent combination of education and experience</li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Strong commitment to quality standards with leadership and management skills.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Ability to read and interpret technical procedures, SOP&rsquo;s, GMP&rsquo;s and governmental regulations.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Strong communication skills, both written and verbal.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Possess positive qualities of effective leadership, staff motivation and conflict resolution.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">Strong attention to detail and ability to multitask.</span></li><li style=\"margin:0in;font-size:13px;font-family: initial;\"><span style=\"font-size:15px;\">ASQC quality certifications, ISO 9000 or other Audit training preferred.</span></li></ul><p><br></p><p style=\"box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; margin-top: 0px; margin-bottom: 1rem; line-height: 1.25;\" data-pasted=\"true\"><span style=\"box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; font-size: 15px;\"><span data-pasted=\"true\" style=\"box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; color: rgb(36, 36, 36); font-family: Aptos, sans-serif; font-size: 14.6667px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; float: none; display: inline !important;\">At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.</span></span></p><p style=\"box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; margin-top: 0px; margin-bottom: 1rem; line-height: 1.25;\"><br style=\"box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; color: rgb(38, 35, 33); font-family: Calibri, sans-serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;\"></p><p><br></p><p><br></p></div></div></div>\n",
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          "nameCode": {
            "codeValue": "IsSassDlReqForIntPostFlag"
          },
          "indicatorValue": false
        },
        {
          "nameCode": {
            "codeValue": "IsMonetaryFlag"
          },
          "indicatorValue": false
        },
        {
          "nameCode": {
            "codeValue": "IsNonMonetaryFlag"
          },
          "indicatorValue": false
        }
      ]
    },
    "requisitionTitle": "DIRECTOR OF QUALITY",
    "clientRequisitionID": "1085",
    "organizationalUnits": [],
    "postingInstructions": [],
    "additionalProperties": {},
    "requisitionLocations": [
      {
        "address": {
          "cityName": "Irvine",
          "postalCode": "92614",
          "countrySubdivisionLevel1": {
            "codeValue": "CA"
          }
        },
        "nameCode": {
          "shortName": " Irvine, CA, US"
        },
        "aliasNames": []
      }
    ],
    "screeningRequirements": [],
    "sponsoredVisaTypeCodes": []
  },
  "detail_meta": {
    "url": "https://workforcenow.adp.com/mascsr/default/careercenter/public/events/staffing/v1/job-requisitions/515459?cid=fbb6193d-556c-4b29-98e5-7306aa3f6384&ccId=19000101_000003&lang=en_US&locale=en_US",
    "http_status": 200,
    "content_type": "application/json;charset=UTF-8",
    "response_bytes": 16330
  },
  "detail_errors": []
}
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GET https://api.bluedoor.sh/job-postings/v1/jobs/ff182f1849c009af07e9e899dddf2e241cb8b5cc?include=descriptionJSON
GET https://api.bluedoor.sh/job-postings/v1/orgs/1c12f03c-6518-4018-9e8a-db5c3c140f34JSON
GET https://api.bluedoor.sh/job-postings/v1/sources/e088055a-0c65-47db-aa4c-74f9b0047486JSON
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