Associate Director Audit, Quality Assurance

Do you have expertise in, and passion for Quality? Would you like to apply your expertise influencing our directions in auditing digital and data solutions? Come join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued.

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. Always committed to lifelong learning, growth and development.

We are now looking for an Associate Director to join our Audit and Inspection team within Quality Assurance R&D.

Quality Assurance is a group of 65 Quality Assurance professionals located at R&D sites worldwide. We work in a highly regulated industry. Patients who participate in clinical trials are vulnerable. Hence there are strict regulations by the health authorities, to protect patients, which we need to follow. The health authorities inspect our activities to make sure we are following and interpreting the regulation as intended. As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mind-set for the benefit of our patients. Here we are forever pushing the boundaries as we feel comfortable spotting opportunities, making quick decisions and taking smart risks.

What you'll do
As Associate Director, QA' based in either Cambridge, UK or Gothenburg, Sweden you will take part of performing global audits within a variety of audit programs: Digital, PV, GCP and vendor. You will manage significant CAPAs related to audit and/or inspection findings in collaboration with functions leading the issues. Delivery of proactive GxP inspection support and management will also be a part of your accountabilities as well as:

* Plan, lead, conduct and report audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits
* Participate in and may lead directed (For Cause) audits
* Work with contract personnel or consultants to prepare, conduct and report outsourced audits
* Support Due Diligence activities as assigned
* Provide responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert
* Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
* Collaborate with Quality Assurance Lead to manage and prepare for regulatory inspections, including providing pre- inspection training to the organisation as needed
* Provide QA oversight and/or management of regulatory GxP inspections
* Assesses need for, and assist in development of CAPA plans, approve and monitor plans to completion

General Accountabilities

* Ensure own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
* Promote a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
* Communicate effectively with QA colleagues and business stakeholders
* Maintain knowledge of relevant industry information affecting quality and compliance arena
* Lead training for colleagues and business stakeholders as the need arises.
* Involved in and may lead the development and/or revision of QA processes, projects and tools
* Mentor QA colleagues
* Provide general support related to regulatory authority inspections as and when required

With this in mind we think that you are an individual with a high degree of integrity and critical thinking agility as well as having a pragmatic attitude and an ability to navigate complex situations. You have a proactive attitude and the personal credibility to effectively communicate and establish trust with stakeholders across the globe.

Essential for the role
We are primarily looking for you that have prior experience in auditing digital and data solutions, with a sound understanding how data is now collected and led in various e-technologies, within either Good Clinical Practice or Pharmacovigilance. However, significant experience of auditing global PV and GCP processes/systems would also be an advantage.

* Degree level education
* Experience in pharmaceuticals or a related industry
* Excellent analytical, written and oral communications skills
* Proficient in written and spoken English
* High ethical standards, trustworthy, operating with absolute discretion
* Skilled at managing & using technology
* Ability to maintain and build professional networks with stakeholders

Why AstraZeneca?
All opinions are valued, all voices are heard - a place of trust and empowerment where everyone is respected as experts to share ideas and make decisions. We see that AstraZeneca is the place to build a rewarding and meaningful career, with great exposure and opportunities at a global pharmaceutical company.

So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Please apply as soon as possible but no later than November 18th, 2021. Welcome with your application!