Associate Director - Pharmacovigilance Auditor - Audit QAL

Do you have expertise as a Pharmacovigilance Auditor? Do you have a passion for promoting and optimising quality and efficiencies? Do you enjoy providing data-driven insights? Would you like to apply your expertise to ensure that quality is a key factor in AstraZeneca's sustainable business success? Then this role might be the one for you!

About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Locations
Gothenburg,Sweden, Warsaw, Poland, Cambridge, United Kingdom.

Business area
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 approach for the benefit of our patients.

R&D QA commits to provide our partners with an experience that is driven by patient protection and data integrity, represents regulators current and future views, optimises quality thinking and promotes a 'right from me' approach, focuses on issues that matter, minimises risks and drives inquisitive outcomes and provides simple, structured and efficient systems, with up-to-date quality information.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!


What you'll do

*

Lead, guide and support the execution of Pharmacovigilance quality assurance audits.
*

Evaluate risk and standards and quality principles including coordinating and facilitating inspections globally.
*

Orchestrate and facilitate critical audits for core GxP areas, including Good Clinical practice, Good Pharmacovigilance Practice and Good Regulator Practice, investigator audits, system or process audits, and vendor audits to support inspection readiness and success.
*

Assess the need for corrective and preventative action. Facilitate the development of Corrective and Protective Action ("CAPA") plans deemed necessary by Quality Assurance lead team members.
*

Assist in leading the development and revision of Quality Assurance processes and procedures.
*

Assess and communicate relevant industry information and changes regarding compliance to colleagues and clients.
*

Work collaboratively with Quality Assurance team members, as well as external consultants, running regulatory inspections, conducting outsourced audits, and providing internal training as needed.


Required Experience, Skills, and Qualifications

*

Bachelor's degree or foreign equivalent in one of the medical sciences (Medicine, Pharmacy, Biology, Chemistry), plus five (5) years of experience designing, conducting, leading and participating in regional and global Pharmacovigilance ("PV") Audits. Alternatively, a Master's degree or foreign equivalent in a related field of study, plus two (2) years of experience as a PV Auditor.
*

25% national and international travel is required to various company and client sites.
*

Monitoring adherence and resolving non-compliance with company policies and applicable regulations including ICH, GCP, and 21 CFR.
*

Performing ad-hoc for cause audits to identify or confirm suspected non-compliance and assist with root cause identification.
*

Managing tools to track, trend, and report GVP audit data.
*

Excellent analytical, written and oral communications skills.
*

High ethical standards, honest, operating with absolute discretion.
*

Strong collaborative, influencing and interpersonal skills - curious to understand business environment.


Desired requirements

*

Experience in leading regulatory health authority GxP Inspections
*

Project management experience
*

Skilled at managing & using various types of technology
*

Ability to maintain and create professional networks with collaborators


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 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, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next:
Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you. NOTE - Due to our summer vacation period in Sweden during July-August, the screening process may take a bit longer than usual. Thanks for your understanding and we will get back to you as soon as possible.

Closing date: 14th August, 2022.