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Associate Director Quality Management - Late Oncology

AstraZeneca UK

Location: Cambridgeshire

Job Type: Full time

Posted


About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. Supportive teammates, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!!

The Associate Director Quality Management (ADQM) is responsible for identification, development, tracking and analysis of quality metrics for their impact on LDO Clinical Operations. They will provide direction and advice on how to use the business processes and existing systems to LDO Clin Ops personnel to enable the delivery of drug and non-drug projects according to agreed high quality standards toward the goal of always inspection-ready.

The ADQM uses global SOPs, processes, procedures, technology and training frameworks to provide compliance advice to their LDO Clin Ops staff; as well as identifies and communicates improvement opportunities to the Process & System Owners. ADQM supports Clin Ops management to oversee the learning needs and trainings delivery as related to Quality Assurance.

Key Responsibilities:

  • Support the execution of the LDO Clinical Operations Quality Framework as the enhanced first line of quality support to ensure the high-quality delivery of clinical trials.

  • Driving strategic focus on quality for the Oncology portfolio with the other functions supporting compliance.

  • Responsible for supporting adherence to GCP and LDO Clinical Operations objectives as defined.

  • Responsible for providing first line quality advice to Study Management Operations (SMO) and Program Management including collaborative compliance consultation on Site Management and Monitoring Oncology activities. The objective is to help facilitate resolution of compliance issues and the adoption and sharing of good practices and learning.

  • Be a significant contributor towards embedding and emphasizing an engaging quality culture in LDO Clinical Operations, with the goal of an ‘always inspection ready’ attitude. Included is defining compliance improvement recommendations, initiatives, and plans. Provision of study/program level support and advice for LDO Clinical Operations during RIST (Regulatory Inspection Support Team) activities.

  • Providing insight and interpretation from the identification, development, or analysis of quality metrics for their impact on LDO Clinical Operations with the goal to strive towards improving performance.

  • Support the facilitation of the quality review meetings with LDO Clinical Operations leadership teams.

  • Actively work in collaboration with other quality functions and partners in the LDO Clinical Operations Quality Network, where the aim is to seek sustainable resolutions on issues.

  • Continually seek opportunities for improvement and feedback from LDO Clinical Operations personnel while supporting a culture of knowledge sharing and learning (e.g. findings from audits and inspections).

  • Identify, calibrate, and track risks, escalate as required and define or support risk mitigation activities.

Requirements:

  • Undergraduate degree in life sciences or an equivalent related field.

  • In-depth knowledge and broad experience within the pharmaceutical (biopharma) industry in a GxP regulated environment.

  • Excellent communication skills with a proven ability to effectively network cross functionally and globally.

  • Critical thinking, influencing and communication skills.

  • Ability to collaborate, network and interact widely and effectively at all levels.

  • Strong risk-based decision-making skills.

  • Excellent understanding of the drug development process and related GXP activities

  • Excellent understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP, study management

  • Excellent knowledge of international regulations and guidelines, as well as AZ Procedural Framework

  • Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization

Desirables:

  • Advanced degree in life sciences or an equivalent related field

  • Experience working with global and remote cross functional teams

  • Ability to work in an environment of remote collaborators

  • Experienced reputation within the business and industry

  • Good cultural awareness

AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

Date Posted

12-Sep-2022

Closing Date

30-Sep-2022

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.