Senior Director, Quality Site Head Cell Therapy

AstraZeneca•Rockville, MD

6d•$200,000 - $310,000•Onsite

About The Position

AstraZeneca is seeking a senior leader to build the planning capability that will support reliable patient supply, successful launches, and long-term growth for its ambitious Cell Therapy portfolios. The Senior Director, Quality Site Head Cell Therapy RMC reports to the Executive Director, Head of Cell Therapy Quality. This role will lead a large Site Quality support function with significant employees and complexities, including other direct and indirect managers. 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 comply with all required procedures and standards. The role will be a key site link into the Cell Therapy Quality (CTQ) organization under Cell Therapy Technical Operations (CTTO).

Requirements

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

Nice To Haves

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

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.
Assesses 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.