Quality Senior Manager (Analytical CMC)

{
  "content_hash": "78be7e751bad8b170fc2b04b71b8c6c57bc65548e1be89d82c7b297363e4ac7f",
  "source_hash": "efcb2eb8b068d609373db1306a29e8bf9505569446a9b40950b0b2353eacd4ee",
  "last_changed_at": "2026-06-19T10:41:02.136Z",
  "active_status": "active"
}

{
  "dedupe": null,
  "language": "en",
  "location": {
    "raw": "Worcester, MA, United States",
    "city": "Worcester",
    "region": "MA",
    "country": "United States",
    "is_remote": false,
    "confidence": 0.8
  },
  "salary_max": 236500,
  "salary_min": 124500,
  "inferred_at": "2026-06-22T11:43:56.303Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "Worcester, MA, United States",
      "city": "Worcester",
      "region": "MA",
      "country": "United States",
      "is_remote": false,
      "confidence": 0.8
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": "hybrid",
  "salary_period": "year",
  "workplace_type": "hybrid",
  "salary_currency": "USD"
}

{}

{
  "id": "3743990013682346",
  "ref": "https://api.smartrecruiters.com/v1/companies/abbvie/postings/3743990013682346",
  "name": "Quality Senior Manager (Analytical CMC)",
  "uuid": "308613b1-76c7-44d1-ab4c-bc7442962874",
  "detail": {
    "id": "3743990013682346",
    "name": "Quality Senior Manager (Analytical CMC)",
    "uuid": "308613b1-76c7-44d1-ab4c-bc7442962874",
    "jobAd": {
      "sections": {
        "jobDescription": {
          "text": "<p>About the Role: We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. &#xa0;You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval.&#xa0; The ideal candidate will have extensive analytical experience, including authoring of analytical and stability regulatory submission sections, a proven track record of excelling in a fast-paced environment, and outstanding attention to detail.&#xa0;</p><p>Scope of responsibilities:</p><ul><li>Author and review new applications and amendments for CTD Module 3 sections S.2, S.4, S.5, and S.7 for regulatory submissions (e.g., BLAs, MAAs, INDs, IMPDs, etc).&#xa0; Support responses to regulatory questions and information requests.</li><li>Provide subject matter expertise in analytical methods, method validation, reference standard qualification, and stability studies.</li><li>Ensure consistency, accuracy, and compliance of submission documents with current regulatory guidance and company standards.</li><li>Remain up to date with regulatory requirements relevant to Module 3 content.</li><li>Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise to deliver results within project timelines.</li><li>Proactively identify risks and propose solutions for documentation challenges.</li><li>Lead cross-functional project meetings to support timelines and project deliverables.</li><li>Interact and collaborate with teams to gather and interpret technical data.</li></ul>",
          "title": "Job Description"
        },
        "qualifications": {
          "text": "<ul><li>Minimum Bachelor’s Degree required preferably in Chemistry, Physical or Life Sciences, Engineering, or related subject; relevant advanced degree preferred.</li><li>8+ years of combined experience in CMC, Manufacturing, QA, QC, R&amp;D in pharmaceutical, or biologics industry.</li><li>4+ years of supervisory/technical leadership experience.</li><li>Extensive authoring experience with Module 3 CTDs (specifically S.2.3, S.4.2, S.4.3, S.5, S.7) for regulatory submissions.</li><li>Proven expertise in analytical/quality control laboratory or CMC regulatory environment.</li><li>Strong understanding of global regulatory requirements and ICH guidelines.</li><li>Demonstrated ability to work effectively on teams and build collaborative relationships across functions.</li><li>Excellent written and verbal communication skills; attention to detail is essential.</li><li>Self-motivated, organized, and capable of managing multiple priorities and deadlines independently.</li><li>Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.</li><li>Must be familiar with use of statistical quality systems and electronic document management system.</li><li>Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.</li></ul>",
          "title": "Qualifications"
        },
        "companyDescription": {
          "text": "<p>AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.abbvie.com%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=ouW0EWAXMc6feS9YMhOrX50Xcr7u7esYey2hTi3aXEs%3D&amp;reserved=0\" rel=\"noopener noreferrer\">www.abbvie.com</a>. Follow @abbvie on&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2Fabbvie&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=NB%2BpWyw5752pXI4BpdVAdYgTngw%2FY%2B2lxdjzuU62mik%3D&amp;reserved=0\" rel=\"noopener noreferrer\">X</a>,&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=pxrMl8T5PQl8HU8Xhph7jSamZXR%2Fqlh%2FTMIodipTPfs%3D&amp;reserved=0\" rel=\"noopener noreferrer\">Facebook</a>,&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=NwEPo8j8wQP42UyWxJuNXoHtRJW9IQ8qnjxx6705e8k%3D&amp;reserved=0\" rel=\"noopener noreferrer\">Instagram</a>,&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=%2Fz0FnNhXfkO2DHSZdZ2mGo6WQ1oEyKQTGDujo0hZDoQ%3D&amp;reserved=0\" rel=\"noopener noreferrer\">YouTube</a>,&#xa0;<a href=\"https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=eBnFZu5pxx5eG%2F%2BGHQXtjVOLh5olOf3QvjuzpAfYi0E%3D&amp;reserved=0\" rel=\"noopener noreferrer\">LinkedIn</a>&#xa0;and&#xa0;<a href=\"https://www.tiktok.com/@abbvie\" rel=\"noopener noreferrer\">Tik Tok</a>.</p>",
          "title": "Company Description"
        },
        "additionalInformation": {
          "text": "<p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&#xa0;local law:&#xa0;​</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company&#xa0;believes in&#xa0;good faith it will pay for this role at the time&#xa0;of this posting based on the job grade for this position.&#xa0;Individual&#xa0;compensation paid within this range will depend on many factors including geographic location, and&#xa0;we&#xa0;may ultimately&#xa0;pay more or less than the posted range. This range may be modified in the&#xa0;future. ​</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&#xa0;medical/dental/vision&#xa0;insurance and 401(k) to eligible&#xa0;employees.​</p></li><li><p>This job is eligible to participate in our short-term incentive&#xa0;programs.&#xa0;​</p></li></ul><p>Note: No amount of pay&#xa0;is considered to be&#xa0;wages or compensation until such amount is earned, vested, and&#xa0;determinable.&#xa0;The amount and availability of any bonus,&#xa0;commission, incentive, benefits, or any other form of&#xa0;compensation and benefits&#xa0;that are allocable to a particular employee remains in the Company's sole and&#xa0;absolute&#xa0;discretion unless and until paid and&#xa0;may be modified at the Company’s sole and absolute discretion, consistent with&#xa0;applicable law.&#xa0;​</p><div sr-tagline=\"\"></div><p>AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&#xa0;</p><p>US &amp; Puerto Rico only - to learn more, visit&#xa0;<a href=\"https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href=\"https://www.abbvie.com/join-us/reasonable-accommodations.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>",
          "title": "Additional Information"
        }
      }
    },
    "jobId": "b7454980-f22e-48b2-8159-e498b2dd167c",
    "active": true,
    "company": {
      "name": "AbbVie",
      "identifier": "AbbVie"
    },
    "creator": {
      "name": "",
      "avatarUrl": ""
    },
    "jobAdId": "89b79a13-8d27-4fea-aaa2-e2a65aca10fb",
    "applyUrl": "https://jobs.smartrecruiters.com/AbbVie/3743990013682346-quality-senior-manager-analytical-cmc-?oga=true",
    "function": {
      "id": "quality_assurance",
      "label": "Quality Assurance"
    },
    "industry": {
      "id": "pharmaceuticals",
      "label": "Pharmaceuticals"
    },
    "language": {
      "code": "en",
      "label": "English",
      "labelNative": "English (US)"
    },
    "location": {
      "city": "Worcester",
      "hybrid": true,
      "region": "MA",
      "remote": false,
      "country": "us",
      "latitude": "42.2628113",
      "longitude": "-71.80249309999999",
      "fullLocation": "Worcester, MA, United States"
    },
    "refNumber": "R00140845",
    "postingUrl": "https://jobs.smartrecruiters.com/AbbVie/3743990013682346-quality-senior-manager-analytical-cmc-",
    "visibility": "PUBLIC",
    "customField": [
      {
        "fieldId": "65806674cbfd1911c2f5d15b",
        "valueId": "10363608",
        "fieldLabel": "Hiring Manager",
        "valueLabel": "Carolyn Sault (10363608)"
      },
      {
        "fieldId": "65807663cbfd1911c2f5d15f",
        "valueId": "FUNCTION_OPQA",
        "fieldLabel": "Workday Function",
        "valueLabel": "OPQA Quality Assurance"
      },
      {
        "fieldId": "657cc8550d0b1f2ef38a3fc9",
        "valueId": "Worcester",
        "fieldLabel": "City",
        "valueLabel": "Worcester"
      },
      {
        "fieldId": "657ccabf0d0b1f2ef38a3fce",
        "valueId": "236500",
        "fieldLabel": "Segment 5 (Maximum)",
        "valueLabel": "236500"
      },
      {
        "fieldId": "657ccbce3fd51d6d84c0bc3a",
        "valueId": "COMPENSATIONGRADE_19",
        "fieldLabel": "Workday Global Grade",
        "valueLabel": "19"
      },
      {
        "fieldId": "6580668ecbfd1911c2f5d15c",
        "valueId": "Associate Director Quality Services and Transformation",
        "fieldLabel": "Hiring Manager Title",
        "valueLabel": "Associate Director Quality Services and Transformation"
      },
      {
        "fieldId": "6580763744b74c1731e95352",
        "valueId": "FUNCTION_OPER",
        "fieldLabel": "Parent Function",
        "valueLabel": "OPER Operations"
      },
      {
        "fieldId": "656747e5a29e121ffd619b85",
        "valueId": "default",
        "fieldLabel": "Brands",
        "valueLabel": "AbbVie"
      },
      {
        "fieldId": "657ccad53fd51d6d84c0bc37",
        "valueId": "124500",
        "fieldLabel": "Salary Min",
        "valueLabel": "124500"
      },
      {
        "fieldId": "657ccae70d0b1f2ef38a3fcf",
        "valueId": "236500",
        "fieldLabel": "Salary Max",
        "valueLabel": "236500"
      },
      {
        "fieldId": "COUNTRY",
        "valueId": "us",
        "fieldLabel": "Country/Region",
        "valueLabel": "United States"
      },
      {
        "fieldId": "657ccc330d0b1f2ef38a3fdb",
        "valueId": "Salaried",
        "fieldLabel": "Salary/Hourly Pay Indicator",
        "valueLabel": "Salaried"
      },
      {
        "fieldId": "657cc8220d0b1f2ef38a3fc8",
        "valueId": "US",
        "fieldLabel": "Workday Country",
        "valueLabel": "United States of America"
      },
      {
        "fieldId": "657cca530d0b1f2ef38a3fcc",
        "valueId": "124500",
        "fieldLabel": "Segment 1 (Minimum)",
        "valueLabel": "124500"
      },
      {
        "fieldId": "657ccc1c0d0b1f2ef38a3fda",
        "valueId": "Job_Family_Quality_Assurance",
        "fieldLabel": "Workday Job Family",
        "valueLabel": "Quality Assurance"
      },
      {
        "fieldId": "657ccc483fd51d6d84c0bc3c",
        "valueId": "COMPENSATIONGRADE_19",
        "fieldLabel": "Posting Grade",
        "valueLabel": "19"
      }
    ],
    "referralUrl": "https://jobs.smartrecruiters.com/external-referrals/company/AbbVie/publication/308613b1-76c7-44d1-ab4c-bc7442962874?dcr_ci=AbbVie",
    "compensation": {
      "max": 236500,
      "min": 124500,
      "period": "YEARLY",
      "currency": "USD"
    },
    "defaultJobAd": true,
    "releasedDate": "2026-06-18T13:07:08.852Z",
    "experienceLevel": {
      "id": "mid_senior_level",
      "label": "Mid-Senior Level"
    },
    "typeOfEmployment": {
      "id": "permanent",
      "label": "Full-time"
    }
  },
  "company": {
    "name": "AbbVie",
    "identifier": "AbbVie"
  },
  "jobAdId": "89b79a13-8d27-4fea-aaa2-e2a65aca10fb",
  "function": {
    "id": "quality_assurance",
    "label": "Quality Assurance"
  },
  "industry": {
    "id": "pharmaceuticals",
    "label": "Pharmaceuticals"
  },
  "language": {
    "code": "en",
    "label": "English",
    "labelNative": "English (US)"
  },
  "location": {
    "city": "Worcester",
    "hybrid": true,
    "region": "MA",
    "remote": false,
    "country": "us",
    "latitude": "42.2628113",
    "longitude": "-71.80249309999999",
    "fullLocation": "Worcester, MA, United States"
  },
  "refNumber": "R00140845",
  "department": {},
  "visibility": "PUBLIC",
  "customField": [
    {
      "fieldId": "65807663cbfd1911c2f5d15f",
      "valueId": "FUNCTION_OPQA",
      "fieldLabel": "Workday Function",
      "valueLabel": "OPQA Quality Assurance"
    },
    {
      "fieldId": "657cc8550d0b1f2ef38a3fc9",
      "valueId": "Worcester",
      "fieldLabel": "City",
      "valueLabel": "Worcester"
    },
    {
      "fieldId": "657ccabf0d0b1f2ef38a3fce",
      "valueId": "236500",
      "fieldLabel": "Segment 5 (Maximum)",
      "valueLabel": "236500"
    },
    {
      "fieldId": "656747e5a29e121ffd619b85",
      "valueId": "default",
      "fieldLabel": "Brands",
      "valueLabel": "AbbVie"
    },
    {
      "fieldId": "COUNTRY",
      "valueId": "us",
      "fieldLabel": "Country/Region",
      "valueLabel": "United States"
    },
    {
      "fieldId": "657cca530d0b1f2ef38a3fcc",
      "valueId": "124500",
      "fieldLabel": "Segment 1 (Minimum)",
      "valueLabel": "124500"
    },
    {
      "fieldId": "657ccc1c0d0b1f2ef38a3fda",
      "valueId": "Job_Family_Quality_Assurance",
      "fieldLabel": "Workday Job Family",
      "valueLabel": "Quality Assurance"
    },
    {
      "fieldId": "657ccc483fd51d6d84c0bc3c",
      "valueId": "COMPENSATIONGRADE_19",
      "fieldLabel": "Posting Grade",
      "valueLabel": "19"
    },
    {
      "fieldId": "65806674cbfd1911c2f5d15b",
      "valueId": "10363608",
      "fieldLabel": "Hiring Manager",
      "valueLabel": "Carolyn Sault (10363608)"
    },
    {
      "fieldId": "657ccbce3fd51d6d84c0bc3a",
      "valueId": "COMPENSATIONGRADE_19",
      "fieldLabel": "Workday Global Grade",
      "valueLabel": "19"
    },
    {
      "fieldId": "6580668ecbfd1911c2f5d15c",
      "valueId": "Associate Director Quality Services and Transformation",
      "fieldLabel": "Hiring Manager Title",
      "valueLabel": "Associate Director Quality Services and Transformation"
    },
    {
      "fieldId": "6580763744b74c1731e95352",
      "valueId": "FUNCTION_OPER",
      "fieldLabel": "Parent Function",
      "valueLabel": "OPER Operations"
    },
    {
      "fieldId": "657ccad53fd51d6d84c0bc37",
      "valueId": "124500",
      "fieldLabel": "Salary Min",
      "valueLabel": "124500"
    },
    {
      "fieldId": "657ccae70d0b1f2ef38a3fcf",
      "valueId": "236500",
      "fieldLabel": "Salary Max",
      "valueLabel": "236500"
    },
    {
      "fieldId": "657ccc330d0b1f2ef38a3fdb",
      "valueId": "Salaried",
      "fieldLabel": "Salary/Hourly Pay Indicator",
      "valueLabel": "Salaried"
    },
    {
      "fieldId": "657cc8220d0b1f2ef38a3fc8",
      "valueId": "US",
      "fieldLabel": "Workday Country",
      "valueLabel": "United States of America"
    }
  ],
  "defaultJobAd": true,
  "releasedDate": "2026-06-18T13:07:08.852Z",
  "detail_errors": [],
  "experienceLevel": {
    "id": "mid_senior_level",
    "label": "Mid-Senior Level"
  },
  "typeOfEmployment": {
    "id": "permanent",
    "label": "Full-time"
  }
}