Senior Validation & Calibration Manager

Do you feel passionate about the possibilities of applying science to changing lives? Do you have experience working within a fast paced Bio, Pharma or regulated industry….. If so, this may be the role for you!

Here at AstraZeneca, you will have the opportunity to make a difference in people’s lives every single day. As one of the world’s premier biotechnology companies our mission is centred on delivering life-changing products, advance world health and helping to fight and cure disease. AstraZeneca has a dynamic environment that champions collaboration and innovation. We attract top minds, and we cultivate and build top talent.

The role is located at AstraZeneca’s manufacturing site a short distance from the exciting city centre of Liverpool. Rich in history, as well being a creative hub, Liverpool offers an attractive cost of living along with a great quality of life. The city has something for everyone; live music, an exciting food and restaurant scene, nationally famous art galleries, excellent shopping and world-class museums.

We have a new opportunity for a Senior Validation & Calibration Manager to join us on a permanent basis as an active member of the sites Engineering Function.

What you’ll do:

  • As a role model – Champion Safety as our number one priority and AstraZeneca Values and behaviours.
  • Collaboration with the wider AstraZeneca network ensuring continued development, optimisation and partner engagement of the Validation /Calibration Management system aligned to AstraZeneca strategy.
  • As Business Process Owner for Validation and Calibration activities – proactively utilise Lean to drive continuous improvement across process and procedures, where appropriate utilising digital technology with the aim of reducing waste and increasing benefit.
  • Development and implementation of the site’s Validation/Calibration strategy to ensure continued compliance with regulatory requirements (cGMP, GAMP, ICH, ISPE); Corporate and site procedures and Good Engineering Practice, providing a high level of customer service as measured via TIER process.
  • Proactive day to day management and performance development of the validation/calibration teams and relevant external service providers to ensure alignment to schedule, efficient delivery of operations and process optimisation.
  • Resource capacity modelling to assure delivery of compliant operations within team and both site & global project portfolio
  • Effective management of assigned Quality Records and Key Quality Documents to ensure timely and effective completion
  • Proactive collaboration across all functions to aid the effective and timely delivery of QMS and change activities.
  • Proactively support the sites Change Management Process and the Change Review Board as Subject Matter Authority.

Skills & Experience

As an experienced Senior Manager, you’ll have a fantastic opportunity to develop and optimise a technical team to deliver critical technical support to the site delivering life changing vaccine to a global market.

To develop, coach and mentor a dedicated and already robust team. We’ll want you to utilise Lean Leadership, continuous improvements and digital technology to optimise and evolve business processes and procedures to ensure continued regulatory compliance.

As a key contributor within an extended management team, this role provides individual development and opportunities to support future career aspirations.

A natural leader, we’re expecting evidence of strong organisational and leadership skills. This will be supported by coaching and mentoring experience.

You’ll be able to demonstrate previous experience leading a multi-disciplined team.

With considerable technical knowledge you’ll be a confident authority in your subject matter.

We’re looking for extensive knowledge of cGMP standards, in particular manufacturing, laboratory and requirements for computer systems (GAMP) and data integrity.

Understanding of GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.

Engineering or Science degree or equivalent in Control and Instrumentation Engineering or Biochemistry, Chemistry, Microbiology, Virology, Biochemical Engineering.

This is a phenomenal opportunity in a very hardworking team. We’ll support you to bring the best out of standout colleagues, and those with a dream to succeed.

We are sure you’ll agree, this is a very rewarding role at an exciting and fast paced site. We look forward to receiving your application, apply today!

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