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Director of Quality Systems

2479a996 4c61 4623 Bd61 684f50d6e2a0 19000101 000001 · Lee, MA, US, Lee, MA · Active · $100,000–$150,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company2479a996 4c61 4623 Bd61 684f50d6e2a0 19000101 000001
TitleDirector of Quality Systems
Normalized title-
Department / team-
LocationLee, MA, United States
Work model-
Employment typeFull Time
Salary$100,000–$150,000 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-05-04 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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City jobsActive postings in Lee.Open
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Linked records

Company2479a996 4c61 4623 Bd61 684f50d6e2a0 19000101 000001
Source95b4d553-a046-4c74-bcb4-9264e4e35c82
ATS providerADP Workforce Now Recruiting

Description

Position Summary The Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with cGMP regulations (21 CFR Parts 210 & 211), FDA aseptic processing guidelines, and EU GMP Annex 1. Duties and Responsibilities Lead the Quality Systems division within the QA Department, supporting the development, clinical, and commercial activities of pharmaceutical and biotech companies. Oversee and maintain Quality Systems to ensure compliance with regulatory requirements. Key areas of focus include Document Control, Training Programs, Complaint Handling, Supplier Management, and Quality Management Systems (QMS). Manage the Complaint Program, ensuring non-conformances are properly documented, investigated, and resolved through effective root cause analysis and corrective/preventive actions. Oversee the Vendor Approval Program, ensuring outside vendors and suppliers meet compliance requirements through qualification and routine audits. Develop and maintain Quality Agreements with clients and critical suppliers to ensure alignment on compliance and quality expectations. Lead the Client Change Notification Program, ensuring timely and accurate communication of company changes to SSM clients. Oversee the Client Audit Program, collaborating with cross-functional teams (Manufacturing, Quality Control, Warehouse, and Engineering) to maintain a continuous state of audit readiness. Support regulatory inspections, working closely with the Head of Quality to prepare for inspections and respond to regulatory agency observations and requests. Prepare and report quality metrics, providing actionable insights to senior leadership for decision-making. Provide client support for ANDA/NDA submissions and pre-PAI/PLI inspections, ensuring compliance with regulatory expectations. Conduct Annual Product Reviews (APRs) for client products, analyzing trends and ensuring ongoing compliance. Stay current with evolving FDA (21 CFR 210/211), EU GMP, and industry regulations, advising executive management on necessary updates to the Quality Management System (QMS) to maintain compliance and drive improvements. Foster strong cross-functional collaboration and ensure cGMP requirements and quality standards are understood and upheld across the organization. Represent Quality Assurance at senior management, project, board, and review meetings, providing strategic input and leadership on quality initiatives. Regulatory Responsibilities Position requires a broad knowledge of life sciences as they relate to the manufacture and testing of pharmaceutical drug products. Thorough knowledge of FDA / EU regulations, particularly as they relate to 21 CFR 210/211 and GMP manufacturing. Supervisory Responsibilities Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines. Experience Minimum of ten (10) years of pharmaceutical experience in a quality role Minimum of five (5) years in a supervisor/managerial role Education Minimum of a Bachelor of Science Degree Master’s Degree preferred Auditor certification from an accredited institute preferred Knowledge, Skills & Abilities In-depth knowledge in current Good Manufacturing Practices (cGMP), analytical chemistry, FDA requirements, ICH guidelines, USP methodology, and EU requirements as they pertain to the pharmaceutical industry . Thorough knowledge of aseptic manufacturing processes. ISO requirements and medical device experience is preferred. Able to travel to vendors, customers and/or other contractual facilities as needed. Technical writing and strong complex problem-solving skills. Ability to effectively and clearly communicate, both written and verbally in English. Detailed oriented Physical Requirements Ability to sit for prolonged periods of time Ability to lift up to 10lbs Ability to stand for prolong periods of time

Full job record

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Source ID95b4d553-a046-4c74-bcb4-9264e4e35c82
Board ID95b4d553-a046-4c74-bcb4-9264e4e35c82
Provideradp_workforcenow
Provider Job Key593179
TitleDirector of Quality Systems
Normalized Title—
Statusactive
Activeyes
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Department—
Team—
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CountryUnited States
RegionMA
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Salary Raw100000.00 To 150000.00 (USD) Annually
Salary Min100,000
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Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=2479a996-4c61-4623-bd61-684f50d6e2a0&ccId=19000101_000001&lang=en_US&type=JS&jobId=593179&jwId=9201148048630_1
Apply URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=2479a996-4c61-4623-bd61-684f50d6e2a0&ccId=19000101_000001&lang=en_US&type=JS&jobId=593179&jwId=9201148048630_1
First Seen At2026-05-31 18:44:29Z
Last Seen At2026-06-06 13:18:53Z
Last Checked At2026-06-06 13:18:53Z
Last Changed At2026-06-06 13:18:53Z
Inactive At—
Source Posted At2026-05-04 18:00:00Z
Source Updated At—
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    "requisitionDescription": "<div><div><table border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"720\" style=\"width:539.75pt;border-collapse:collapse;border:none;\" id=\"isPasted\"><tbody><tr><td valign=\"top\" style=\"width: 21.6667%; border: 1pt solid windowtext; padding: 0in 5.4pt; height: 27.4pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Position Summary</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; padding: 0in 5.4pt; height: 27.4pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:6.05pt;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;text-align:justify;'><span style='font-size:15px;font-family:\"Calibri\",sans-serif;color:black;'>The Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with cGMP regulations (21 CFR Parts 210 &amp; 211), FDA aseptic processing guidelines, and EU GMP Annex 1.</span></p></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 114.25pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;text-align:justify;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Duties &nbsp; &nbsp; &nbsp;&nbsp;</span></strong></p><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;text-align:justify;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>and Responsibilities</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 114.25pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 9.5px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Lead the Quality Systems division within the QA Department, supporting the development, clinical, and commercial activities of pharmaceutical and biotech companies.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Oversee and maintain Quality Systems to ensure compliance with regulatory requirements. Key areas of focus include Document Control, Training Programs, Complaint Handling, Supplier Management, and Quality Management Systems (QMS).</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Manage the Complaint Program, ensuring non-conformances are properly documented, investigated, and resolved through effective root cause analysis and corrective/preventive actions.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Oversee the Vendor Approval Program, ensuring outside vendors and suppliers meet compliance requirements through qualification and routine audits.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Develop and maintain Quality Agreements with clients and critical suppliers to ensure alignment on compliance and quality expectations.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Lead the Client Change Notification Program, ensuring timely and accurate communication of company changes to SSM clients.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Oversee the Client Audit Program, collaborating with cross-functional teams (Manufacturing, Quality Control, Warehouse, and Engineering) to maintain a continuous state of audit readiness.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Support regulatory inspections, working closely with the Head of Quality to prepare for inspections and respond to regulatory agency observations and requests.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Prepare and report quality metrics, providing actionable insights to senior leadership for decision-making.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Provide client support for ANDA/NDA submissions and pre-PAI/PLI inspections, ensuring compliance with regulatory expectations.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Conduct Annual Product Reviews (APRs) for client products, analyzing trends and ensuring ongoing compliance.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Stay current with evolving FDA (21 CFR 210/211), EU GMP, and industry regulations, advising executive management on necessary updates to the Quality Management System (QMS) to maintain compliance and drive improvements.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Foster strong cross-functional collaboration and ensure cGMP requirements and quality standards are understood and upheld across the organization.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Represent Quality Assurance at senior management, project, board, and review meetings, providing strategic input and leadership on quality initiatives.</span></li></ul></div></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 27.4pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Regulatory Responsibilities &nbsp;</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 27.4pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:8.3pt;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;margin-top:3.0pt;margin-bottom:  3.0pt;text-align:justify;'><span style='font-size:15px;font-family:\"Calibri\",sans-serif;color:black;'>Position requires a broad knowledge of life sciences as they relate to the manufacture and testing of pharmaceutical drug products. Thorough knowledge of FDA / EU regulations, particularly as they relate to 21 CFR 210/211 and GMP manufacturing.</span></p></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 2.5pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Supervisory Responsibilities</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 2.5pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 11.8px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines.&nbsp;</span></li></ul></div></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 23.15pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Experience</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 23.15pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 11.8px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Minimum of ten (10) years of pharmaceutical experience in a quality role</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;'>Minimum of five (5) years in a supervisor/managerial role &nbsp;</span></li></ul></div></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 19.75pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Education</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 19.75pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 11.8px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Minimum of a Bachelor of Science Degree</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;'>Master&rsquo;s Degree preferred&nbsp;</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;'>Auditor certification from an accredited institute preferred&nbsp;</span></li></ul></div></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 44.5pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Knowledge, Skills &amp; Abilities</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 44.5pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 11.8px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;'>In-depth knowledge in current Good Manufacturing Practices (cGMP), analytical chemistry,<span style=\"color:black;\">&nbsp;</span>FDA requirements, ICH guidelines, USP methodology, and EU requirements <span style=\"color:black;\">as they pertain to the pharmaceutical industry</span>.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Thorough knowledge of aseptic manufacturing processes.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>ISO requirements and medical device experience is preferred.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;color:black;'>Able to travel to vendors, customers and/or other contractual facilities as needed.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;'>Technical writing and strong complex problem-solving skills.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;'>Ability to effectively and clearly communicate, both written and verbally in English.</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:  \"Calibri\",sans-serif;font-size:15px;'>Detailed oriented</span></li></ul></div></td></tr><tr><td valign=\"top\" style=\"width: 21.6667%; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; padding: 0in 5.4pt; height: 30.1pt; vertical-align: top;\"><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'>Physical Requirements</span></strong><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;'> </span></strong></p><p style='margin-right:0in;margin-left:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin:0in;'><strong><span style='font-size:15px;font-family:\"Calibri\",sans-serif;color:#FF6600;'>&nbsp;</span></strong></p></td><td valign=\"top\" style=\"width: 78.3333%; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; padding: 0in 5.4pt; height: 30.1pt; vertical-align: top;\"><div style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 11.8px;\"><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Ability to sit for prolonged periods of time</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Ability to lift up to 10lbs</span></li><li style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style='font-family:\"Calibri\",sans-serif;font-size:15px;color:black;'>Ability to stand for prolong periods of time</span></li></ul></div></td></tr></tbody></table></div></div>\n",
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