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The Director QA acts as Designated Representative ( Quality Assurance, Director, Distribution, Assurance, Quality, Global Supply, Business Services\n","descriptionText","Director, Quality Assurance - Distribution Gilead Sciences Creative & Design The Director Quality Assurance, US market, a member of the Global Product Distribution & Affiliates (GPD&A) group, is responsible for supporting distribution of Gilead products within the US market. The Director QA acts as Designated Representative ( Quality Assurance, Director, Distribution, Assurance, Quality, Global Supply, Business Services","shortDescription","The Director Quality Assurance, US market, a member of the Global Product Distribution & Affiliates (GPD&A) group, is responsible for supporting di...","location","San Mateo, California, United States, 94409","companyName","Gilead Sciences","salaryMin","salaryMax","salaryDescription","https://us.thebigjobsite.com/redirectfeedjob?jobid=CC51DDBFC39E42FC51426E2DFD13ACB1&source=mediabistroxmlus&utm_source=mediabistroxmlus&jobSiteKey=7FAC6B580D24635D61521FE5A2DE5DBE","companyDescription","companyWebsite","displayLogo","https://www.mediabistro.com/public/images/desk-100x50.webp","displayThumbnail","displayHeadline","Work at Gilead Sciences","isManualPosted","costPerClick",0.15,"displayUrl","fullUrl","https://www.mediabistro.com/jobs/2462365871-director-quality-assurance-distribution","strippedDescription","parsedLocation",{"_463":464,"_465":466,"_467":468,"_469":191,"_470":191,"_471":472},"city","San Mateo","state","California","country","United States","street1","street2","postal_code","94409","displayPublishedAt","10 hours ago","shortTitle","shortLocation","level","searchCompanyPath","/jobs?keyword=Gilead+Sciences","searchLocationPath","/jobs?location=San+Mateo%2C+California%2C+United+States%2C+94409","searchTitlePath","/jobs?keyword=Director%2C+Quality+Assurance+-+Distribution","featuredCompany",{"_422":486,"_15":487,"_488":425,"_74":489,"_490":491,"_240":492,"_439":493,"_494":-5,"_495":-5,"_496":-5,"_497":-5,"_498":499,"_500":501,"_449":489,"_457":502,"_451":489},211,"Mansueto Ventures","agency","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/109473.JPG","slug","mansueto-ventures-careers","

Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[507,521,533,541,549],{"_426":425,"_430":508,"_449":450,"_441":509,"_240":510,"_437":511,"_424":425,"_111":512,"_428":191,"_429":191,"_451":450,"_439":513,"_422":514,"_452":515,"_427":115,"_473":516,"_457":517,"_475":512,"_476":513,"_478":518,"_480":519,"_482":520},["D",1770026400000],"Scorpion Therapeutics","Role Summary

The Senior Director, Quality Assurance - Distribution is accountable for QA operations in US, Canada and LATAM to ensure GMP and GDP compliance for Gilead products. The role develops QA strategies to strengthen and harmonize GDP compliance across the regions and sits on the GPD&A leadership team, contributing to strategy, governance, and operational development of Quality Distribution and QA Operations across markets.\nResponsibilities

Serve as a key member of the GPD&A Leadership Team, implementing cohesive and effective QA processes across the distribution network and developing medium- and long-term strategic plans for all regions to support the overall quality organization.\nCoach and mentor direct reports to drive independence, development, and performance, and provide leadership to ensure a safe, respectful, and inclusive work environment.\nManage financial budget, resources, and workload to ensure local QA activities meet timelines and quality/compliance expectations; monitor KPIs and project milestones and provide prioritization guidance as needed.\nAct as Senior QA advisor to in-country and cluster QA leads with interpreting local and regional regulatory requirements for distribution of Gilead products.\nAct as senior liaison with distribution partners in US, Canada & LATAM regarding escalations, major issues, and changes affecting business models with these partners.\nInterface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates.\nProvide leadership for local market activities supporting product recalls and readiness for recall or other market actions.\nLead highly complex investigations and develop/implement CAPA as required.\nPartner with QA colleagues to develop strategies supporting in-country QA operations, including standards, processes, and procedures.\nCollaborate cross-functionally with quality groups, Regulatory Affairs, Global Trade Ops, Global Commercial Operations, Legal, and external distribution partners to establish strong working relationships.\nAct as an internal escalation contact for complex and high-impact quality issues and decisions.\nLead cross-functional regional/global projects and process improvement initiatives with significant business impact.\nAct as deputy for the Executive Director as required, supporting complex and high-impact quality-related issues and escalations.\nQualifications

14+ years of relevant experience with a bachelor’s degree in science or related field, or 12+ years with an advanced science degree (MS, MD, PharmD, PhD) or an MBA; or 20+ years in pharmaceutical warehouse and distribution.\nComprehensive knowledge and experience in quality assurance within highly regulated distribution environments.\nPrior people management experience.\nBroad experience across customer service, warehouse operations, logistics and transport; understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial.\nSkills

Deep understanding and application of GDP principles across US, Canada, LATAM and awareness in other regions.\nAbility to develop complex concepts, techniques, standards, and new applications based on quality principles.\nAnticipates shifts in industry trends and regulatory environments to position the function to respond.\nStrong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.\nAbility to develop innovative solutions to complex problems where precedents may not exist.\nExtensive knowledge of industry best practices and trends; excellent verbal, written, and interpersonal communication and influencing skills.\nComfort interacting with regulatory agencies and representing Gilead in public forums.\nAbility to identify, understand, and exceed customer expectations; experience in managing staff.\nExperience initiating and supporting change and driving continuous improvement aligned with organizational strategy.\nEducation

Bachelor’s degree in science or related field required for 14+ years of experience; advanced degree (MS, MD, PharmD, PhD) or MBA permitted for 12+ years of experience.

#J-18808-Ljbffr\n","Role Summary

The Senior Director, Quality Assurance - Distribution is accountable for QA operations in US, Canada and LATAM to ensure GMP ...","Senior Director, Quality Assurance - Distribution","San Francisco, California, United States, 94199",["B","2404995667"],"Work at Scorpion Therapeutics","4 days ago","/jobs/2404995667-senior-director-quality-assurance-distribution","/jobs?keyword=Scorpion+Therapeutics","/jobs?location=San+Francisco%2C+California%2C+United+States%2C+94199","/jobs?keyword=Senior+Director%2C+Quality+Assurance+-+Distribution",{"_426":425,"_430":522,"_449":450,"_441":523,"_240":524,"_437":525,"_424":425,"_111":512,"_428":191,"_429":191,"_451":450,"_439":526,"_422":527,"_452":528,"_427":115,"_473":529,"_457":530,"_475":512,"_476":526,"_478":531,"_480":532,"_482":520},["D",1769724000000],"Gilead Sciences, Inc.","* Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium- and long-term strategic plans for all regions, which supports the overall strategic plans for the quality organization.* Coach and mentor direct reports to drive independence, development, and performance & provide leadership to ensure a safe, respectful, and inclusive work environment.* Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations in an equitable manner as well as ensuring that key performance indicators are monitored and reported, and key project timelines & milestones are tracked. Provides guidance on prioritization when necessary.* Act as Senior QA advisor to in-country & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products* Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, as well as with changes that impact Gilead’s business models with these partners* Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.* Provide leadership for local market activities across US, Canada & LATAM regions supporting product recall and support periodic product recall challenges to ensure Gilead’s in-country distribution operations are in a state of continuous readiness in the event of needing to support product recall or other types of market action.* Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA), as required.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, Global Trade Ops, Global Commercial Operations & Legal functions as well as other Gilead global functions and external distribution partners.* Act as an internal escalation contact supporting complex and high impact quality issues, concerns, and decisions.* Prime QA representative on cross-functional regional/global projects & process improvement initiatives of considerable impact to the business.* Act as deputy for the Executive Director, as required**,** supporting complex and high impact quality-related issues, escalations & other topics.* 14+years of relevant experience and a bachelor’s degree in science or related fields, or 12+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, 20+years relevant experience in pharmaceutical warehouse & distribution required.* Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.* Prior people management experience required.* Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial.* Demonstrates in-depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM as well as having an appreciation of them in other regions across the globe.* Capable of developing complex concepts, techniques, and standards and new applications based on quality principles and theories.* Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the function to respond accordingly* Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.* Capable of developing solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.* Demonstrates extensive knowledge of industry best practices and trends.* Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.* Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.* Demonstrates the ability to identify, understand and exceed customer expectations.* Demonstrates experience and ability to manage staff.* Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy.\n#J-18808-Ljbffr\n","* Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes acro...","Foster City, California, United States, 94420",["B","2351185819"],"Work at Gilead Sciences, Inc.","8 days ago","/jobs/2351185819-senior-director-quality-assurance-distribution","/jobs?keyword=Gilead+Sciences%2C+Inc.","/jobs?location=Foster+City%2C+California%2C+United+States%2C+94420",{"_426":425,"_430":534,"_449":450,"_441":523,"_240":535,"_437":525,"_424":425,"_111":512,"_428":191,"_429":191,"_451":450,"_439":536,"_422":537,"_452":528,"_427":115,"_473":538,"_457":539,"_475":512,"_476":536,"_478":531,"_480":540,"_482":520},["D",1769147589000],"* Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium- and long-term strategic plans for all regions, which supports the overall strategic plans for the quality organization.* Coach and mentor direct reports to drive independence, development, and performance & provide leadership to ensure a safe, respectful, and inclusive work environment.* Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations in an equitable manner as well as ensuring that key performance indicators are monitored and reported, and key project timelines & milestones are tracked. Provides guidance on prioritization when necessary.* Act as Senior QA advisor to in-country & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products* Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, as well as with changes that impact Gilead’s business models with these partners* Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.* Provide leadership for local market activities across US, Canada & LATAM regions supporting product recall and support periodic product recall challenges to ensure Gilead’s in-country distribution operations are in a state of continuous readiness in the event of needing to support product recall or other types of market action.* Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA), as required.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.* Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, Global Trade Ops, Global Commercial Operations & Legal functions as well as other Gilead global functions and external distribution partners.* Act as an internal escalation contact supporting complex and high impact quality issues, concerns, and decisions.* Prime QA representative on cross-functional regional/global projects & process improvement initiatives of considerable impact to the business.* Act as deputy for the Executive Director, as required**,** supporting complex and high impact quality-related issues, escalations & other topics.* 14+years of relevant experience and a bachelor’s degree in science or related fields, or 12+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, 20+years relevant experience in pharmaceutical warehouse & distribution required.* Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments.* Prior people management experience required.* Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial.* Demonstrates in-depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM as well as having an appreciation of them in other regions across the globe.* Capable of developing complex concepts, techniques, and standards and new applications based on quality principles and theories.* Anticipates shifts in industry trends and regulatory environment that will impact Gilead’s business needs and positions the function to respond accordingly* Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.* Capable of developing solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.* Demonstrates extensive knowledge of industry best practices and trends.* Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.* Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.* Demonstrates the ability to identify, understand and exceed customer expectations.* Demonstrates experience and ability to manage staff.* Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy.
#J-18808-Ljbffr","Foster City",["B","1965253199"],"14 days ago","/jobs/1965253199-senior-director-quality-assurance-distribution","/jobs?location=Foster+City",{"_426":425,"_430":542,"_449":450,"_441":442,"_240":543,"_437":544,"_424":425,"_111":545,"_428":191,"_429":191,"_451":450,"_439":440,"_422":546,"_452":453,"_427":115,"_473":516,"_457":547,"_475":545,"_476":440,"_478":479,"_480":481,"_482":548},["D",1770058800000],"Join a forward-thinking company dedicated to tackling global health challenges. As a Director of QA Compliance, you will play a pivotal role in ensuring the effectiveness of Gilead's audit programs and compliance with regulatory standards. This position is vital for overseeing audits of suppliers and enhancing the quality oversight program. With a focus on collaboration and leadership, you will drive improvements and maintain high compliance standards across biologics operations. If you are passionate about making a difference in healthcare and possess extensive experience in the pharmaceutical industry, this is the opportunity for you to shine and impact lives positively.\n#J-18808-Ljbffr\n","Join a forward-thinking company dedicated to tackling global health challenges. As a Director of QA Compliance, you will play a pivotal role in ens...","Global QA Compliance Director Biologics Audits",["B","2408837554"],"/jobs/2408837554-global-qa-compliance-director-biologics-audits","/jobs?keyword=Global+QA+Compliance+Director+Biologics+Audits",{"_426":425,"_430":550,"_449":450,"_441":523,"_240":551,"_437":552,"_424":425,"_111":553,"_428":191,"_429":191,"_451":450,"_439":536,"_422":554,"_452":528,"_427":115,"_473":555,"_457":556,"_475":553,"_476":536,"_478":531,"_480":540,"_482":557},["D",1770332133000],"A leading biopharmaceutical company is looking for a Senior QA leader to manage quality assurance processes across its distribution network. The ideal candidate has 14+ years of experience in quality assurance and regulatory environments, along with strong leadership and communication skills. This role is pivotal in ensuring compliance and driving continuous improvement across operations in various regions.
#J-18808-Ljbffr","A leading biopharmaceutical company is looking for a Senior QA leader to manage quality assurance processes across its distribution network. The id...","Global QA Director, Distribution & Compliance",["B","2449766093"],"1 days ago","/jobs/2449766093-global-qa-director-distribution-compliance","/jobs?keyword=Global+QA+Director%2C+Distribution+%26+Compliance","actionData","errors"]