QA Director for Batch Release, Complaints and Stability, Operational Excellence, External Quality (EQ)

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted

Perfection not required
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Work on diversified tasks with a distributed team:

Welcome to External Quality (EQ), a global Quality organization within AZ Operations where the community is vibrant and we never stop developing! We are now looking for our new QA Director to help us manage compliance and quality license to operate activities while we are vastly growing across all of our multiple business areas. This is a place where you will feel included in the conversation, where every voice is heard and makes a difference.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

The QA Director for Batch Release, Stability and Complaints is a global quality leadership role were you will be working across our multiple business areas (ESM Q, Procurement Q, GSC&S Q), supply regions and supply sites in EMEA, US and APAC to ensure we are meeting the current and future business supply needs. The role reports into the Head of Operational Excellence within EQ, and is a member of the Operational Excellence leadership team. Overseeing our batch release activities, supplier stability studies coordination and complaint investigations for EQ you will be central to lead the team that will assure compliance and deliver support to the business to assure we meet the needs of our external operations product portfolio and new product introduction plans for small and large molecules.

The team of Operational Excellence in EQ has a key role in protecting the AZ reputation and license to operate globally by constantly improving and maintaining the External Quality Management System (EQMS). In addition, the team is responsible for the deployment of Strategy, People & Development, BPM, LEAN and IT across the whole of EQ.

Sweden (Södertälje or Gothenburg) or UK (Macclesfield).

What you’ll do

  • Oversee a team of approx. 10 FTEs across Sweden, UK and US that supports EQ Operational activities such as batch release, supplier stability studies coordination and complaints investigations from market, regulatory authorities, suppliers and operations sites
  • Drive and deliver strong execution and performance in EQ batch release, complaint investigations and stability studies coordination processes through the team
  • Assure continuous improvements, harmonization and optimize internal ways of working in your area of responsibility reflecting a productivity improvement of ~5% year by year
  • Provide senior support och leadership to your team when managing investigations including the implementation of solutions for the resolution of quality issues facing external suppliers and sites
  • Develop the capabilities and ensure sufficiently trained resources with adequate product and process knowledge for execution of the GMP/GDP obligations of your team
  • Coordinate and develop the External Regulatory Audit management process, support hosting activities for Regulatory audits of the aligned MIA
  • Support maintenance of EQ GMP licensing and registration for externally manufactured APIs and Formulated products
  • Represent AstraZeneca internally at Quality and Review meetings, IMTs, Tier and Project meetings and externally in partnering Organizations or other Professional Bodies as necessary.
  • Engage and collaborate with EQ Engagement Team, Sr Leadership team to drive engagement, wellbeing, sustainability and people talent development in our teams

Essentials for the role:

  • Master or Bachelor degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering. Note: there may be specific additional requirements depending on the regulations in each country
  • Knowledge of both chemical and biological medicinal product manufacture with significant pharmaceutical industry experience in GMP/GDP, quality and/or manufacturing and/or regulatory affairs
  • Previous experience as Qualified Person or being QP eligible in Sweden and/or UK
  • Strong leadership capabilities from previous managerial roles
  • Strong professional communication skills, verbal and written English
  • Personal resilience/emotional intelligence
  • Strong risk and problem management skills that requires evaluative judgements
  • High Ability for Conceptual thinking, contributes and leads change to increase performance
  • Good understanding of Supply Chain capability and Lean Manufacture
  • High Ability to work both independently and in partnership in a complex global supply chain environment
  • Good business and financial understanding
  • Good partner management skills


Desirables for the role:

  • Multi-site / multi-functional experience
  • Previous experience from Biologics and/or sterile manufacturing
  • Knowledge about emerging technologies and trends required to secure capabilities and competence for the future
  • Proven strong interpersonal and leadership skills focus on achieving goals through teams
  • Previous experience from leading change management initiatives across multiple business areas with a track record delivering business benefit
  • Ability to negotiate, persuade and influence others, ability to resolve conflicts
  • Passion for people and talent development
  • Experience in working with a matrix organization

Be empowered to be innovative and creative where difference is valued

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel 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. Always committed to lifelong learning, growth and development.

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel 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. Always committed to lifelong learning, growth and development.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Welcome with your application no later than 9th October. Our screening process will start before closing date so don't hesitate to apply.

Opening date: 2022-09-22
Closing Date: 2022-10-09
Competitive salary and benefits package on offer.

Date Posted

22-sep.-2022

Closing Date

09-okt.-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.

You’ve got this!