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 standards of behavior and ways of working

• Works with colleagues on the Site Leadership Team to ensure that the site strategy delivers on the needs of CTTO and its customers/patients

Qualifications

• 15+ years applicable experience with B.S. degree in Science, Engineering, Biochemistry Pharmacy or related technical field

• 12+ years applicable with M.S. degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

• 5+ years direct autologous Cell Therapy experience

• 5+ years management experience

• 3+ years Cell Therapy Quality experience including clinical lot release

• Experience with product launches, health authority inspections and global commercial product distribution requirements

• Proven ability to work in a fast-paced environment across multiple technical functions

• Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply

• Proven track record of attracting and developing talent

• Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance

• Ability to influence senior stakeholders, both internally and externally

Desirable Qualifications

• PhD in Science, Engineering, Biochemistry, Pharmacy or related technical field

• Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company’s values

• Experience with Cell Therapy IND and MA submissions

• Experience with Cell Therapy regulatory inspections

• Experience engaging with global regulatory bodies

• Allogenic Cell Therapy experience

When 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 the Rockville, MD 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 $200,000 to $310,000. 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 Posted

Closing Date

Our 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.