Gaithersburg, MD, USA
Posted by: Astra Zeneca
05 May

Director, Team Lead, Audit QA

Gaithersburg, MD, USA
Job Description

As ‘Director, QA’ based in Gaithersburg, USA you will be the Team Lead for the group of auditors delivering the R&D QA Audit Program for GCP, GVP, Data Integrity and external vendors. You will work alongside a variety of stakeholders inside R&D QA and within the AZ R&D organisation to ensure the effective delivery of audits within the Audit Program. You will work with other senior members of the Audit QA function to maximise audit resource, identify areas to support training and development needs of those within your team. As a senior member of QA, you will form part of the Audit QA Leadership Team, bringing experience and depth of knowledge to help drive audit strategy forwards.

As such the role is varied and provides leadership opportunities across a broad range of disciplines. For example, you will lead and develop individuals within the USA based audit team, ensure delivery of audits performed within the USA team. Also, you will be required to provide expert audit support to more complex or sensitive directed audits. Your experience of managing Regulatory Inspections (e.g. FDA, EMA) will be essential.  You will be recognised as a leader in your field and as leader of people.

This role will act as ‘site lead’ for QA in Gaithersburg, USA and have a dotted reporting line into the QA Leadership Team (QALT). As an extended arm of the QALT, the role will ensure QA staff present in USA have a ‘voice’ at QA leadership and are strongly supported with local matters.


With that in mind the role is best suited to candidates with a high degree of integrity and strategic thinking agility. It is also important to have a ‘solutions focused’ attitude and the ability to generate simple solutions to complex challenges. Importantly, you will need to have a proactive ‘Business Partnering’ mindset and the personal credibility to effectively communicate and establish trust with senior stakeholders and leadership teams across the globe. This is critical to enable you to influence decisions and thereby sustain the Quality Mindset.

Job ID Reference
Desired Skills & Experience

To be successful in this role you will need:

  • Bachelors' Degree level education
  • Significant experience in pharmaceuticals or a related industry
  • Excellent analytical, written and oral communications skills
  • Fluent in written and spoken English
  • High ethical standards, trustworthy, operating with absolute discretion
  • Strong collaborative, influencing and interpersonal skills – curious to understand business environment
  • Skilled at managing & using technology
  • Ability to maintain and create professional networks with stakeholders
  • Experience in managing regulatory health authority Inspections
  • Audit expertise
  • Demonstrable leadership skills and experience
  Gaithersburg, Maryland, USA
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
 Gaithersburg, MD, USA