Director, Cell Therapy Quality Management

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction

The Director, Cell Therapy Quality Management (Dir. CT QM) role will work in a collaborative manner with other members of the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) team in order to provide expert quality advice and coaching so as to support the successful delivery of Cell Therapy Programmes.

The Dir. CT QM role will function to support the teams across CTCO in order to ensure that all CTCO trials are prepared for both internal and external audits and inspections.

The Dir. CT QM role has a specific area of expertise within CTCO BPQL in the following manner:

Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards.

Deliver or drive the development of quality-related initiatives and continuous improvement programmes that would support improved Quality and Compliance within CTCO trials and within CTCO-related processes and initiatives.

First line of Quality support to all CTCO trials and CTCO-related initiatives.

To operate within established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality, Learning & Transformation (PQLT).

Accountabilities

CT BPM works closely with the BPQL team, ensuring:

Insights related to CTCO-specific process-related issues requiring corrective actions are documented for potential future process improvements.
Process KPIs & measurement: Support development, using quality-related data to inform process and business improvement activities.
Perform effectiveness checks as needed to support the remediation of study-related CAPAs and if needed to verify the uptake and adoption of new and changed CTCO-related processes.

Escalate, as needed, to 2nd Line Quality and the broader CTQN any issues or risks related to any CTCO-related studies or initiatives

Communicate on a routine basis, relevant quality-related insights and feedback to the greater CTCO organization

Education, Qualifications, Skills and Experience

Essential

Bachelor of Science in an appropriate discipline or equivalent experience

At least 7 years of relevant operational and/or quality experience in Drug Development within a pharmaceutical or clinical background

Strong knowledge of business process, technology and Clinical Study information knowledge

Demonstrated time management acumen and proven skills to deliver responses and suppor

Experience in working successfully and collaboratively with both internal and external partners

Demonstrated strong written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills

Strong knowledge of Clinical Trials related international regulations, guidelines and standards (ICH GCP, FDA, EMA regulations and guidelines as minimum), as well as AZ internal standards and procedures, across functions

Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus

Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership and accountability

Desirable

Strong reputation within the business and industry

Strong understanding and knowledge regarding Cell Therapy-relevant procedures

Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement

Experience in the development and management of Business Process to deliver business performance