At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. Our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease. Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a multifaceted, inspiring culture where we celebrate diverse, ambitious thinking and act with a sense of urgency.
We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
The 'R&D Quality Assurance Audit team' provides excellence in auditing, quality management, quality risk assessment, and enhancement of the R&D quality mindset for the benefit of our patients across the R&D operations at AstraZeneca.
As 'Associate Director, QA' based in either Gothenburg, Sweden or Barcelona, Spain you will be responsible for performing global audits within a variety of audit programs: Digital, PV, GCP, and vendor.
For this current opportunity, we are seeking an individual with prior experience in auditing within either Good Clinical Practice or Pharmacovigilance processes/systems. Experience within auditing digital and data solutions, with a sound understanding of how data is now collected and utilized in various e-technologies is also essential.
The successful person will be responsible for:
Audits: Plans, leads, conducts, and reports 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.
Works with contract personnel or consultants to prepare, conduct, and report outsourced audits.
Supports Due Diligence activities as assigned.
Inspection Support: Collaborates with Quality Assurance Lead to manage and prepare for regulatory inspections, including providing pre-inspection training to the organization as needed.
Provides QA oversight and/or management of regulatory GxP inspections.
CAPA: Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion.
General Accountabilities: Provides responsive and proactive quality and compliance advice to defined customers, effectively influences assigned area by being relevant GxP/quality system expert. Supports quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations.
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