Quality System Manager, Quality Systems & Documentation
Location: Cheshire East
Job Type: Full time
Do you want to drive the future of Quality when we embark on our journey transforming to digital? Use your interest for IT systems and Quality to 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).
Our Quality System Manager plays an important role in our Quality IT system and Quality processes by overseeing and executing reliable and efficient operations for these areas. This includes among other activities incident management, IT system upgrades and implementing IT efficiencies (e.g., automation) and process improvements. The QSM seeks to ensure and improve so that the performance and security meet the users’ needs. You will do this in close collaboration with Users, Business Process Owners and IT support organisations.
You will work across many interfaces, orums, process networks, with leaders in Development functions (PT&D, PhSci & DevQ) and IT Governance forums . You will drive improvement projects through these interfaces to develop and implement organisational objectives. You will develop and maintain in-depth knowledge applicable to the area of the Quality regulations and guidelines.
In the role, you will coordinate a group of system specialists and super-users, who sits globally across Development functions: PT&D, PhSci and DevQ.
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 have excellent knowledge of IT systems, system security and troubleshooting, as well as excellent knowledge of Microsoft applications and preferable Minitab. You have an Analytical and data-driven attitude, you show engagement and are used to influencing partners at all seniority levels. You are a driven problem-solver, a skilled communicator who is able to make decisions and act courageously, inspiring others in the process. You will keep abreast of IT technology trends and developments to ensure the organisation is at the forefront of development.
Other essentials you will need:
- Experience of working in a regulated environment
- Experience in virtual collaboration to lead, shape and develop innovative solutions
- Good team working and networking skills
- Demonstrates independent judgement and uses risk management
- Builds good relationships both internally and with external suppliers or service providers
- Demonstrates a high degree of personal credibility
Desirables for the role
- Experience of working with and managing third party suppliers/vendors
- Experience of working in a global organisation with a complex/geographical context
- Cross-industry business awareness/business domain knowledge
- LeanSix Sigma certification
- Experience and skills in facilitation and how to apply Lean SixSigma methodologies
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 the 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.