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Associate Director Post Marketing Quality

5478ada3 7f50 4778 91cf 21507e4e8cea 19000101 000001 · US · Deleted · $165,000–$180,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company5478ada3 7f50 4778 91cf 21507e4e8cea 19000101 000001
TitleAssociate Director Post Marketing Quality
Normalized title-
Department / team-
LocationUnited States
Work model-
Employment typeFull Time
Salary$165,000–$180,000 / year
Statusdeleted
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-10 / 2026-05-31
Changed / last seen2026-06-02 / 2026-05-31

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Linked records

Company5478ada3 7f50 4778 91cf 21507e4e8cea 19000101 000001
Sourcea5111b02-b460-43f0-b3dc-ff397acc7c6f
ATS providerADP Workforce Now Recruiting

Description

The Associate Director of Post-Marketing Quality Assurance is responsible for leading quality oversight activities that ensure continued compliance of commercial pharmaceutical products throughout their lifecycle. This role provides strategic and operational oversight of third party logistics centers, distribution partners, and pharmacovigilance interfaces to ensure regulatory compliance, product quality, and supply continuity. This person will also represent quality on the commercial launch team to ensure implementation of these elements are incorporated into product launch timelines. The Associate Director will drive post-approval quality strategy, manage quality systems related to commercial products, support inspections, and partner cross-functionally with Regulatory Affairs, Supply Chain, Safety, and Technical Operations. Roles & Responsibilities Manage product complaints, field alerts, and product recalls. Assure close collaboration with medical affairs and product safety teams. Lead for potential defective product, serious deviation, or recall/Field Corrective Actions and reporting appropriate Regulatory Agency. Identify quality and performance objectives; analyze metrics and report trends to management. Participate in supplier qualification activates (e.g., conduct supplier audits, develop and implement quality agreements, etc.). Oversight of suppliers involved in the packaging, labeling and distribution of Arcutis commercial products. Ensure timely investigation, root cause analysis, and CAPA implementation. Release of Finished Products for distribution in US. Label and artwork review and approval for US. Review of batch-related documentation to ensure GMP compliance for release of Finished Product. Oversight of deviation investigations for packaging and shipping events. Provide QA oversight and approval of Change Control records impacting product distribution, implementation, and management of jurisdictional control. Ensure distribution procedures align with expectations and requirements for US FDA, and other country/state boards of health as required. Author and/or revise controlled documents related to various Quality Systems (e.g. SOPs, Controlled Forms, Work Instructions, etc.). Other duties that may be assigned. Education & Licenses and Experience Bachelor’s degree preferred or at least 5 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. ASQ Auditor certification a plus. Competencies & Skills Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements. Comfortable using quality tools such as lean, six sigma, risk management and other risk-based tools to continually improve operations. Ability to successfully interact with regulatory health authorities. Ability to lead and influence cross functional employees to ensure compliance. Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Proficient in MS Word, Excel, Power Point. Veeva QMS a plus. Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). Strong knowledge of GMP, SOPs and quality systems as they relate to document management. Why Join Us? Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission! Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. California Employee/Applicant Privacy Notice

Full job record

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TitleAssociate Director Post Marketing Quality
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First Seen At2026-05-31 18:48:00Z
Last Seen At2026-05-31 18:48:00Z
Last Checked At2026-06-02 08:56:25Z
Last Changed At2026-06-02 08:56:25Z
Inactive At2026-06-02 08:56:25Z
Source Posted At2026-04-10 16:00:00Z
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    "requisitionDescription": "<p data-pasted=\"true\"><span style=\"font-size: 16px;\">The <strong>Associate Director of Post-Marketing Quality Assurance</strong> is responsible for leading quality oversight activities that ensure continued compliance of commercial pharmaceutical products throughout their lifecycle. This role provides strategic and operational oversight of third party logistics centers, distribution partners, and pharmacovigilance interfaces to ensure regulatory compliance, product quality, and supply continuity. This person will also represent quality on the commercial launch team to ensure implementation of these elements are incorporated into product launch timelines.</span></p><p><span style=\"font-size: 16px;\">The Associate Director will drive post-approval quality strategy, manage quality systems related to commercial products, support inspections, and partner cross-functionally with Regulatory Affairs, Supply Chain, Safety, and Technical Operations.</span></p><p><br></p><p><span style=\"font-size: 16px;\"><strong><u>Roles &amp; Responsibilities</u></strong></span></p><ol style=\"list-style-type: decimal;margin-left: -0.25in;\"><li style=\"font-size: 16px;\">Manage product complaints, field alerts, and product recalls. Assure close collaboration with medical affairs and product safety teams.</li><li style=\"font-size: 16px;\">Lead for potential defective product, serious deviation, or recall/Field Corrective Actions and reporting appropriate Regulatory Agency.</li><li style=\"font-size: 16px;\">Identify quality and performance objectives; analyze metrics and report trends to management.&nbsp;</li><li style=\"font-size: 16px;\">Participate in supplier qualification activates (e.g., conduct supplier audits, develop and implement quality agreements, etc.).</li><li style=\"font-size: 16px;\">Oversight of suppliers involved in the packaging, labeling and distribution of Arcutis commercial products.&nbsp;</li><li style=\"font-size: 16px;\">Ensure timely investigation, root cause analysis, and CAPA implementation.</li><li style=\"font-size: 16px;\">Release of Finished Products for distribution in US.&nbsp;</li><li style=\"font-size: 16px;\">Label and artwork review and approval for US.</li><li style=\"font-size: 16px;\">Review of batch-related documentation to ensure GMP compliance for release of Finished Product.</li><li style=\"font-size: 16px;\">Oversight of deviation investigations for packaging and shipping events.</li><li style=\"font-size: 16px;\">Provide QA oversight and approval of Change Control records impacting product distribution, implementation, and management of jurisdictional control.</li><li style=\"font-size: 16px;\">Ensure distribution procedures align with expectations and requirements for US FDA, and other country/state boards of health as required.</li><li style=\"font-size: 16px;\">Author and/or revise controlled documents related to various Quality Systems (e.g. SOPs, Controlled Forms, Work Instructions, etc.).</li><li style=\"font-size: 16px;\">Other duties that may be assigned.</li></ol><p><br></p><p><span style=\"font-size: 16px;\"><strong><u>Education &amp; Licenses and Experience</u></strong></span></p><p><span style=\"font-size: 16px;\">Bachelor&rsquo;s degree preferred or at least 5 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. ASQ Auditor certification a plus.</span></p><p><br></p><p><span style=\"font-size: 16px;\"><strong><u>Competencies &amp; Skills</u></strong></span></p><ul style=\"list-style-type: disc;margin-left: -0.25in;\"><li style=\"font-size: 16px;\">Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements.</li><li style=\"font-size: 16px;\">Comfortable using quality tools such as lean, six sigma, risk management and other risk-based tools to continually improve operations.</li><li style=\"font-size: 16px;\">Ability to successfully interact with regulatory health authorities.&nbsp;</li><li style=\"font-size: 16px;\">Ability to lead and influence cross functional employees to ensure compliance.</li><li style=\"font-size: 16px;\">Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management.</li><li style=\"font-size: 16px;\">Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.</li><li style=\"font-size: 16px;\">Proficient in MS Word, Excel, Power Point. Veeva QMS a plus.</li><li style=\"font-size: 16px;\">Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).</li><li style=\"font-size: 16px;\">Strong knowledge of GMP, SOPs and quality systems as they relate to document management.</li></ul><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; line-height: 1.25; margin-top: 0px; margin-bottom: 1rem; color: rgb(38, 35, 33); font-family: Circular, -apple-system, \"system-ui\", \"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);'><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; line-height: 1.25; margin-top: 0px; margin-bottom: 1rem; color: rgb(38, 35, 33); font-family: Circular, -apple-system, \"system-ui\", \"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);' data-pasted=\"true\"><strong 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-weight: 700;\">Why Join Us?&nbsp;</strong></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; line-height: 1.25; margin-top: 0px; margin-bottom: 1rem; color: rgb(38, 35, 33); font-family: Circular, -apple-system, \"system-ui\", \"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);'>Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!<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;\">&nbsp;</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; line-height: 1.25; margin-top: 0px; margin-bottom: 1rem; color: rgb(38, 35, 33); font-family: Circular, -apple-system, \"system-ui\", \"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);'>Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.&nbsp;</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; line-height: 1.25; margin: 0in; color: rgb(38, 35, 33); 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; font-family: Calibri, sans-serif;\"><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;\"></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; line-height: 1.25; margin: 0in; color: rgb(38, 35, 33); 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; font-family: Calibri, sans-serif;\"><a target=\"_blank\" href=\"https://www.arcutis.com/wp-content/uploads/Employee-Applicant-Privacy-Notice.pdf\" rel=\"noopener noreferrer\" 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(50, 79, 165); font-weight: 400; text-decoration: none;\">California Employee/Applicant Privacy Notice</a></p>\n",
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      ]
    },
    "requisitionTitle": "Associate Director Post Marketing Quality",
    "clientRequisitionID": "1286",
    "organizationalUnits": [],
    "postingInstructions": [],
    "additionalProperties": {},
    "requisitionLocations": [
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    "screeningRequirements": [],
    "sponsoredVisaTypeCodes": []
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  "detail_meta": {
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}
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