Team Lead, Quality Systems & Documentation
Location: Cheshire East
Job Type: Full time
Do you want to drive the future of Quality when we embark on our transformation journey to digital? Use your interest for IT systems to lead people in a company that follows the science and turns ideas into life changing medicines!
Our Development Quality team ensures the delivery of safe, effective and compliant medicines to patients participating in global clinical studies. We set standards and apply scientific and Quality expertise to our exciting drug pharmaceutical development portfolio and help maintain our reputation and license to operate. We also play an important part in the commercialisation of new medicines, working closely with our colleagues in Operations and R&D. Development Quality is a Global group, with teams located in Macclesfield, (UK), Gothenburg (Sweden), Durham (North Carolina, US), Redwood City (US) and Bad Homburg (Germany).
The team leader is a key role for the development and implementation of Quality IT, this role will have a strategic focus on working in a global and corporate arena and building successful team. You will ensure the team drive cross-functional change management projects involving IT systems, Quality Processes and Quality infrastructure. You are accountable for effective and reliable Quality IT systems and Quality processes in Development (PT&D, PharmSci and DevQ). You ensure high availability and effective use of the Quality IT systems and that the License to Operate is robust in the Development functions and that GMP standards ensure patient safety throughout the progression of the AZ project portfolio.
You will set the standards for Quality Leadership to ensure that the team is an influential, proactive and valuable partner in the broader Development organisation and Global organisation. You will interpret external and AZ regulatory, GMP standards and expectations into appropriate quality standards. This to provide guidance and Quality Leadership to IT project teams/functions to ensure AstraZeneca and Regulatory requirements are met.
The Team Lead is responsible for taking GMP compliance decisions, having a major impact on AZ’s business and external reputation. Your decisions are made against a background of Quality expectations and regulations that vary and require your interpretation.
As a leader you will ensure that your team is well organized and resourced with the right competences to deliver the accountabilities of the team. You will coach, develop and inspire the people in your team so that you together can reach the goals whilst maintaining our license to operate.
Essential for the role
You have a scientific degree with extensive experience (5-10 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation. You need a broad and wide-ranging understanding of Quality Systems and GMP and comprehensive understanding of the pharmaceutical/drug development process. Interest and experience of GMP related IT systems and hands-on experience with IT technical projects is a must. You are a problem-solver, a skilled communicator who is able to make decisions and act courageously, inspiring others in the process. Other essentials you will need:
- Experience in driving cross functional change management projects
- Knowledge and experience of Business Process Management
- Excellent team working and networking skills and encourages team effectiveness
- Demonstrates independent judgement and uses risk management in complex situations
- Demands excellence, shows energy and deliver to make a difference
- Builds excellent relationships both internally and with external suppliers or service providers
- Demonstrates a high degree of personal credibility
- Ability to initiate, develop and take strategic initiatives and can translate into tactical solutions
- Experience in Business Process Management and how to apply Lean methods and Tool
- Capability work with confident in a Global context with many interfaces, you need ability to influence and coordinate improvement projects across businesses
Desirables for the role
- Experience from working in a Quality Assurance function is beneficial
- LeanSix Sigma certification
At 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.
Are you already imagining yourself joining our team – good, because we can’t wait to hear from you.
We look forward to your application no later than 2nd October, 2022. Interviews will be held during the advertisement period so don’t hesitate to apply! Curious for more information, contact Anders Karlsson (Director Quality Systems and Strategy).
Opening date: 2022-09-14
Closing Date: 2022-10-02
Competitive salary and benefits package on offer
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.