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Director, Quality Assurance

3948ea79 Af48 4172 9522 827dec1165d6 19000101 000001 · King of Prussia, PA, US, King of Prussia, PA · On Site · Active · ADP Workforce Now Recruiting

Job facts

FieldValue
Company3948ea79 Af48 4172 9522 827dec1165d6 19000101 000001
TitleDirector, Quality Assurance
Normalized title-
Department / team-
LocationKing of Prussia, PA, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-24 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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Provider filtered searchThe same provider as a filtered job collection.Open
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Work model jobsActive On Site postings.Open
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Linked records

Company3948ea79 Af48 4172 9522 827dec1165d6 19000101 000001
Sourcee0b15f33-7abc-4846-a170-6bbdecd3f982
ATS providerADP Workforce Now Recruiting

Description

Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most. Franklin Biolabs, Inc. is in search of a Director, Quality Assurance who will l ead and oversee the Quality Assurance department with a focus on GMP analytical activities performed for clients, ensuring data integrity, regulatory compliance, and inspection readiness across multiple programs, sponsors, and testing platforms. Ensure compliance with regulatory requirements, industry and company standards. Job Summary: Lead continuous gap analyses of regulatory requirements, and drive implementation of solutions aligned with business priorities. Assist with the development and execution of a quality assurance strategy aligned with the company's objectives. Direct regulatory inspection readiness, as well as QA support of client quality needs. Ensure that customer audit and regulatory inspections are managed appropriately including response to observations with corrective and preventative actions documented and communicated, as necessary. Continuously improve core QMS processes: document control, CAPA, deviation and investigation management, audit response, and change control. Foster a culture of quality and compliance for the organization. Assist with the management and communication of departmental budgets and goals for the Quality Assurance unit. Manage Quality Assurance team members, ensuring their development, engagement, and performance. Drive cross-functional collaboration and alignment to achieve quality and compliance objectives. Perform additional duties as assigned. Education and Experience: Minimum of a BS required, advanced degree preferred in a scientific/technical discipline 10+ years of direct related experience in a CRO, biological and/or pharmaceutical industry with experience in cell and gene therapy. 5+ years of experience in a leadership or management role within the quality function. Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities. Experience leading Quality Assurance oversight of GMP analytical activities. Knowledge, Skills and Abilities: Strong knowledge of Good Manufacturing Practice (GMP) requirements. Knowledge of GLP, Good Clinical Laboratory Practice (GCLP) /Clinical Laboratory Improvement Amendments (CLIA) Knowledge of regulatory compliance and agencies (USDA, OLAW, FDA, AAALAC) including animal care and use. Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Expertise in root cause analysis. Ability to apply regulations and international guidelines to all aspects of the position Ability to write reports, business correspondence, and procedure manuals. Track record of successfully leading Quality and compliance initiatives in a regulated environment. Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to employees, management, executive leadership, public groups, and/or boards of directors. Leadership and people management skills, with the ability to inspire and develop a high performing team. Ability to assess and utilize software and custom programs to meet QA and organizational needs. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and all levels of the organization. Ability to translate business objectives into actionable Quality strategies and initiatives. Travel: Ability to travel domestically and/or internationally up to 15% of the time, depending on the needs of the project, the client and the company. Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients. On-Site: This position requires full-time on-site presence at our Discovery Labs location. Immunizations and Screenings: This position requires access to lab and lab animal spaces Essential Status: Essential for Research: This position may be required to go on-site to perform their regular work functions related to continued research during periods of adjusted operations. This would not likely be required to go on-site during a company closure under normal business operations. Vision: Ability to distinguish between different colors (normal color vision). Ability to see clearly at various distances. Adequate near vision for reading documents or lab equipment. Ability to focus and maintain concentration in tasks for extended periods. Ability to work in environments with varying light conditions. Company Benefits: 401(k) 401(k) Matching Health insurance Dental insurance Vision insurance Health Savings Account and Flexible Spending Account Paid Time-Off Company Paid Holidays Personal Floating Holidays Short-Term and Long-Term Disability Life and AD&D insurance (Group & Voluntary)

Full job record

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TitleDirector, Quality Assurance
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First Seen At2026-05-31 18:57:29Z
Last Seen At2026-06-06 12:57:51Z
Last Checked At2026-06-06 12:57:51Z
Last Changed At2026-06-06 12:57:51Z
Inactive At—
Source Posted At2026-04-24 16:06:00Z
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    "requisitionDescription": "<p><span style=\"color: rgb(38, 35, 33); font-family: arial, 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; float: none; display: inline !important;\" data-pasted=\"true\">Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson&#39;s laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.</span></p><p><span data-pasted=\"true\"><span style=\"color: rgb(38, 35, 33); font-family: arial, 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; float: none; display: inline !important;\" data-pasted=\"true\">Franklin Biolabs, Inc. is in search of a Director, Quality Assurance who will</span><span style='color: rgb(38, 35, 33); font-family: Circular, -apple-system, BlinkMacSystemFont, \"Segoe UI\", Roboto, Oxygen, Ubuntu, Cantarell, \"Fira Sans\", \"Droid Sans\", \"Helvetica Neue\", 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; display: inline !important; float: none;' data-pasted=\"true\"> l</span></span><span style=\"font-size: 16px;\">ead and oversee the Quality Assurance department with a focus on GMP analytical activities performed for clients, ensuring data integrity, regulatory compliance, and inspection readiness across multiple programs, sponsors, and testing platforms. Ensure compliance with regulatory requirements, industry and company standards.</span></p><p><span style=\"font-size: 18px;\"><strong>Job Summary:</strong></span></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Lead continuous gap analyses of regulatory requirements, and drive implementation of solutions aligned with business priorities.</li><li style=\"margin-left: 0in; font-size: 16px;\">Assist with the development and execution of a quality assurance strategy aligned with the company&#39;s objectives.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Direct regulatory inspection readiness, as well as QA support of client quality needs. Ensure that customer audit and regulatory inspections are managed appropriately including response to observations with corrective and preventative actions documented and communicated, as necessary.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Continuously improve core QMS processes: document control, CAPA, deviation and investigation management, audit response, and change control.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Foster a culture of quality and compliance for the organization.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Assist with the management and communication of departmental budgets and goals for the Quality Assurance unit.</li><li style=\"margin-left: 0in; font-size: 16px;\">Manage Quality Assurance team members, ensuring their development, engagement, and performance.</li><li style=\"margin-left: 0in; font-size: 16px;\">Drive cross-functional collaboration and alignment to achieve quality and compliance objectives.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Perform additional duties as assigned.</li></ul></div><p><span style=\"font-size: 16px;\"><span style=\"font-size: 18px;\" data-pasted=\"true\"><strong>Education and Experience:</strong></span></span></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Minimum of a BS required, advanced degree preferred in a scientific/technical discipline</li><li style=\"margin-left: 0in; font-size: 16px;\">10+ years of direct related experience in a CRO, biological and/or pharmaceutical industry with experience in cell and gene therapy.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">5+ years of experience in a leadership or management role within the quality function.</li><li style=\"margin-left: 0in; font-size: 16px;\">Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Experience leading Quality Assurance oversight of GMP analytical activities.</li></ul><p><span style=\"font-size: 16px;\" data-pasted=\"true\"><span style=\"font-size: 18px;\" data-pasted=\"true\"><strong>Knowledge, Skills and Abilities:</strong></span></span></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Strong knowledge of Good Manufacturing Practice (GMP) requirements.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Knowledge of GLP, Good Clinical Laboratory Practice (GCLP) /Clinical Laboratory Improvement Amendments (CLIA)&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Knowledge of regulatory compliance and agencies (USDA, OLAW, FDA, AAALAC) including animal care and use.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Expertise in root cause analysis.</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to apply regulations and international guidelines to all aspects of the position</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to write reports, business correspondence, and procedure manuals.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Track record of successfully leading Quality and compliance initiatives in a regulated environment.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Ability to effectively present information to employees, management, executive leadership, public groups, and/or boards of directors.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Leadership and people management skills, with the ability to inspire and develop a high performing team.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Ability to assess and utilize software and custom programs to meet QA and organizational needs.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and all levels of the organization.</li><li style=\"margin-left: 0in; font-size: 16px;\" data-pasted=\"true\">Ability to translate business objectives into actionable Quality strategies and initiatives.</li></ul><p><span style=\"font-size: 16px;\" data-pasted=\"true\"><span style=\"font-size: 18px;\" data-pasted=\"true\"><strong>Travel:</strong></span></span></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Ability to travel domestically and/or internationally up to 15% of the time, depending on the needs of the project, the client and the company.&nbsp;</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.</li></ul></div><p><span style=\"font-size: 16px;\"><span style=\"font-size: 18px;\"><strong>&nbsp;On-Site:</strong></span></span></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">This position requires full-time on-site presence at our Discovery Labs location.</li></ul><p><strong><span style=\"font-size: 18px;\">Immunizations and Screenings:</span></strong></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">This position requires access to lab and lab animal spaces&nbsp;</li></ul><p><strong><span style=\"font-size: 18px;\">Essential Status:</span></strong></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Essential for Research: This position may be required to go on-site to perform their regular work functions related to continued research during periods of adjusted operations. This would not likely be required to go on-site during a company closure under normal business operations.</li></ul><p><strong><span style=\"font-size: 18px;\">Vision:</span></strong></p><div style=\"margin-left:0in;\" data-pasted=\"true\"><ul style=\"list-style-type: disc;\"><li style=\"margin-left: 0in; font-size: 16px;\">Ability to distinguish between different colors (normal color vision).</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to see clearly at various distances.</li><li style=\"margin-left: 0in; font-size: 16px;\">Adequate near vision for reading documents or lab equipment.</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to focus and maintain concentration in tasks for extended periods.</li><li style=\"margin-left: 0in; font-size: 16px;\">Ability to work in environments with varying light conditions.</li></ul></div><p><strong><span style=\"font-size: 18px;\"> </span></strong><span style=\"box-sizing: border-box; --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: 18px; font-family: arial, sans-serif;\"><strong style=\"box-sizing: border-box; --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-weight: 700;\">Company Benefits:</strong></span></p><ul data-pasted=\"true\" style='box-sizing: border-box; --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: Circular, -apple-system, BlinkMacSystemFont, \"Segoe UI\", Roboto, Oxygen, Ubuntu, Cantarell, \"Fira Sans\", \"Droid Sans\", \"Helvetica Neue\", 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; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; background-color: rgb(255, 255, 255); list-style-type: disc;'><li style=\"margin-left:0in;\" data-pasted=\"true\">401(k)</li><li style=\"margin-left:0in;\">401(k) Matching</li><li style=\"margin-left:0in;\">Health insurance</li><li style=\"margin-left:0in;\">Dental insurance</li><li style=\"margin-left:0in;\">Vision insurance</li><li style=\"margin-left:0in;\">Health Savings Account and Flexible Spending Account</li><li style=\"margin-left:0in;\">Paid Time-Off</li><li style=\"margin-left:0in;\">Company Paid Holidays</li><li style=\"margin-left:0in;\">Personal Floating Holidays</li><li style=\"margin-left:0in;\">Short-Term and Long-Term Disability</li><li style=\"margin-left:0in;\">Life and AD&amp;D insurance (Group &amp; Voluntary)</li></ul></div></div></div></div></div>\n",
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            "codeValue": "IsMonetaryFlag"
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          "indicatorValue": false
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        {
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          "indicatorValue": false
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      ]
    },
    "requisitionTitle": "Director, Quality Assurance",
    "clientRequisitionID": "1058",
    "organizationalUnits": [],
    "postingInstructions": [],
    "additionalProperties": {},
    "requisitionLocations": [
      {
        "address": {
          "cityName": "King of Prussia",
          "postalCode": "19406",
          "countrySubdivisionLevel1": {
            "codeValue": "PA"
          }
        },
        "nameCode": {
          "shortName": " King of Prussia, PA, US"
        },
        "aliasNames": []
      }
    ],
    "screeningRequirements": [],
    "sponsoredVisaTypeCodes": []
  },
  "detail_meta": {
    "url": "https://workforcenow.adp.com/mascsr/default/careercenter/public/events/staffing/v1/job-requisitions/950562?cid=3948ea79-af48-4172-9522-827dec1165d6&ccId=19000101_000001&lang=en_US&locale=en_US",
    "http_status": 200,
    "content_type": "application/json;charset=UTF-8",
    "response_bytes": 17835
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  "detail_errors": []
}
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