Senior Director, Quality Site Head Cell Therapy

If you have the passion and the drive to accelerate growth and make people’s lives better – then AstraZeneca is the place for you.  In Cell Therapy Technical Operations (CTTO) we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. 

AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery.  AstraZeneca is accelerating fast. AstraZeneca is on track for Our Bold Ambition 2030, delivering 15+ new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules. 

The Opportunity

AstraZeneca 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 RMC reports to the Executive Director, Head of Cell Therapy Quality. The role 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 in their span of control. They will ensure products manufactured and/or controlled by operations and its contractors, if applicable, comply with all required procedures and standards. Role will be a key site link into the Cell Therapy Quality (CTQ) organization under Cell Therapy Technical Operations (CTTO).

Responsibilities

• Leads, creates and staffs the Quality organizational structure for the Rockville Manufacturing Site (RMC) to support current pivotal clinical supply and future commercial supply with a sizeable team.  

• Contributes to the multidisciplinary team responsible to manufacture novel Cell Therapy products for current pivotal clinical supply and future commercial supply

• Leads 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-budget

• Develops innovative Quality strategies with a sense of urgency to enable potentially life-saving medicines to reach patients

• Assess the implications of CTTO strategies to develop and implement CTQ recommendations

• Monitors the evolving CTQ landscape to position CTTO for success

• Partners with senior leaders across CTTO and CTQ to identify and remove blockers to ensure delivery of an integrated approach across the business

• Owns 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 site

• Leads 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 requirements

• Oversees core Site Quality processes, including, but not limited to, product release and auditing of compliance against the appropriate procedures and standards

• Supports overall relationship with the regulatory bodies, including dealing with and resolving any site issues raised

• Supports the AstraZeneca Global Quality network relationship on behalf of the site / area of accountability

• Accountable for Business Unit performance and effectiveness of the function.  Ensuring 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 operate

• Responsible for expenditure versus budget within own Business Unit and in the wider context of the site

• Drives the development of the Site Leadership Team by setting common objectives and appropriate stand