Senior Director, Quality Site Head Cell Therapy
$207k - $300kAstraZeneca
The OpportunityAstraZeneca is building one of the industry’s most ambitious Cell Therapy portfolios, spanning autologous, allogeneic, and in vivo modalities. As the business evolves from clinical-stage operations to global commercial scale, we are seeking a senior leader to build the planning capability that will support reliable patient supply, successful launches, and long-term growth.The Senior Director, Quality Site Head Cell Therapy will lead a large Site Quality support function with significant number of employees and complexities, including other direct and indirect managers. Job requires extensive oversight across a range of Site Quality business areas. The role holder will efficiently deliver the Quality portion of the site manufacturing plan on time and to the required standards of Good Manufacturing Practices as well as Safety, Health, and Environment compliance. They will manage the cost of delivering Quality Assurance, Quality Control, and Quality Systems & Compliance to all operational areas within their span of control. They will ensure products manufactured and/or controlled by operations and their contractors, if applicable, comply with all required procedures and standards. Role will be a key site link into the Cell Therapy Quality (CTQ) org under Cell Therapy Technical Operations (CTTO).ResponsibilitiesLeads, creates, and staffs the Quality organizational structure for the Tarzana & Santa Monica Manufacturing Sites to support current clinical supply and future commercial supplyContributes to the multidisciplinary team responsible for manufacturing novel Cell Therapy products for current clinical supply and future commercial supplyLeads the efficient delivery of Quality Assurance, Quality Control, and Quality Systems & Compliance to facilitate delivery of the site manufacturing plan to the required procedures and standards on-time and on-budgetDevelops innovative Quality strategies with a sense of urgency to enable potentially life-saving medicines to reach patientsAssess the implications of CTTO strategies to develop and implement CTQ recommendationsMonitors the evolving CTQ landscape to position CTTO for successPartners with senior leaders across CTTO and CTQ to identify and remove blockers to ensure delivery of an integrated approach across the businessOwns the Site Quality strategy and Quality Management System (QMS) business process and therefore is accountable for the delivery and management of the QMS across the siteLeads Site Quality initiatives and improvement programs aimed at ensuring compliance, continuous improvement, enhancing commitment to quality, and improving COGM, while ensuring that required procedures and standards meet internal requirementsOversees core Site Quality processes, including, but not limited to, product release and auditing of compliance against the appropriate procedures and standardsSupports overall relationship with the regulatory bodies, including dealing with and resolving any site issues raisedSupports the AstraZeneca Global Quality network relationship on behalf of the site / area of accountabilityAccountable for Business Unit performance and effectiveness of the function. Ensures that resources are appropriately justified, managed, and developed effectively (including performance and attendance management), while ensuring compliance with Good Manufacturing Practices as well as Safety Health and Environment compliance and maintaining site’s license to operateResponsible for expenditure versus budget within own Business Unit and in the wider context of the siteDrives the development of the Site Leadership Team by setting common objectives and appropriate standards of behaviors and ways-of-workingWorks with colleagues on the Site Leadership Team to ensure that the site strategy delivers on the needs of CTTO and its customers/patientsMinimal Required Qualifications15+ years applicable experience with B.S. degree in Science, Engineering, Biochemistry Pharmacy or related technical field12+ years applicable with M.S. degree in Science, Engineering, Biochemistry, Pharmacy or related technical field5+ years direct autologous Cell Therapy experience5+ years management experience3+ years Cell Therapy Quality experience including clinical lot releaseExperience with product launches, health authority inspections and global commercial product distribution requirementsProven ability to work in a fast-paced environment across multiple technical functionsDemonstrated ability to make decisions under pressure that balance patient safety, compliance and supplyProven track record of attracting and developing talentExtensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidanceAbility to influence senior stakeholders, both internally and externallyPreferred QualificationsPhD in Science, Engineering, Biochemistry, Pharmacy or related technical fieldDemonstrated track record in leadership of change management in a positive and non-disruptive manner to the company’s valuesExperience with Cell Therapy IND and MA submissionsExperience with Cell Therapy regulatory inspectionsExperience engaging with global regulatory bodiesAllogenic Cell Therapy experienceWhen we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average a minimum of three days per week from either the Santa Monica, CA or Tarzana, CA office location. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.The annual base salary for this position ranges from $207,000 to $300,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Date Posted05-Oct-2026Closing Date05-Oct-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US – Tarzana – CA; US – Santa Monica Colorado Avenue – CAType: Full time
$138k - $207k
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