At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people globally and by leading breakthrough science that promises to transform the treatment of disease. Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking and act with a sense of urgency. We are curious, creative, and open to new ideas and ways of working.

We work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity, even in the most difficult situations because we are committed to doing the right thing.

We believe in the potential of our people and you’ll develop beyond what you thought possible! We will make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us.

We are currently recruiting for an Associate Director: Development Quality Systems & Processes to strengthen our team.

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 play an important part in the commercialisation of new medicines, working closely with our colleagues in Operations. We are a Global group, with teams located in Macclesfield, (UK), Gothenburg (Sweden), Durham (North Carolina, US), Gaithersburg (US), Redwood City (US) and Bad Homburg (Germany).

The Associate Director is accountable for three Quality areas of R&D Quality Infrastructure; Pharmaceutical Management system (PQS), Management Review (MR) and Issue Management process (IMT). As a member of the Development Quality Extended Leadership Team, you will design and deliver the strategic direction for the three areas.

The Associate Director sets the standards for the Development Quality organisation regarding Quality Leadership to ensure that Development Quality is seen as an influential, proactive and valuable partner in the broader development organisation.

This is a phenomenal opportunity to further build your network, and to interact with a wide range of individuals at all levels, in a very dynamic environment. In this role you will have the opportunity to really impact and drive the culture and performance within Quality.

Accountabilities/Responsibilities

• Chairperson of the PQS Improvement Board and member of the QCM Committee; drives the consistent application of the Quality Policy, GMP standards and practices across PharmSci and PT&D, and monitors and interprets new and emerging global GMP legislation or guidelines that apply to the overall Quality System, whilst assessing the business impact and proactively identifying the changes required to the Development function’s processes and compliance procedures
• Leads issue management teams on compliance issues e.g. recalls and complaints to assure patient safety while resolving compliance issues
• Sponsors and drives functional and cross-functional quality improvement projects
• Ensures appropriate Quality input to major business improvement projects
• Drives a strong lean culture, promoting standardisation, simplification and continuous improvement
• Responsible for the legal Qualified Person (QP) certification of Products and delivering the roles and responsibilities of the QP as defined in EU and national regulations

In addition and as responsible for the three areas, you will be the Business Process Owner for:

• The Development Pharmaceutical Quality System
• The Management Review process
• The Issue Management Team process

To be successful in this role, you will have strong leadership skills and will be a recognised Global specialist in the overall scope of the Quality System, Quality Assurance and GMPs, both within AstraZeneca and externally. You will operate with an integrated mindset to create an organisation with common processes and ways of working. Contributing influentially across the Development functions, you will demonstrate Quality Leadership, collaboration and business acumen. You will be entrepreneurial, with a passion for working with stakeholders, driving improvements and leading complex situations and strategies.

Minimum Requirements– Education and Experience

• Appropriate bachelors’ degree with extensive experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
• A comprehensive understanding of the pharmaceutical/drug development process
• A comprehensive practical ability and profound knowledge of Quality risk management
• An understanding of the clinical supply chain business
• Experience of Quality Assurance Management; a broad and comprehensive understanding of Quality Systems and GMP or other GXP areas
• Substantial knowledge and reputation in the QA arena and specifically in GMP matters
• Experience of coaching and developing people, developing and leading matrix teams
• Eligible Qualified Person
• Lean experience

Desirable Requirements:

• Lean or Six Sigma certification
• Project Management qualification
• Experience of working in a Global organisation

Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey!

Date Posted

Closing Date

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.