AstraZeneca Pharmaceuticals LP Director Audit Inspection, GMD Transformation in Gothenburg, Sweden
Global Medicine Development drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. We are responsible for enabling the business to make critical pipeline and investment decisions, to ensure they select the right molecules to progress and to seize the right lifecycle management opportunities – generating the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their true value.
We are now looking to hire a Director Audit Inspection, who will drive the evolution of Inspection Management process to support the Science Units. You will develop the audit program and lead complex audits in several GxP areas. Furthermore, you will be responsible for expert evaluation of risk, standards and quality principles by establishing effective internal and external networks to maintain broad industry experience. Placement for the role is at AstraZeneca Gothenburg, Sweden or Cambridge, UK. Travel is expected.
At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Main Duties and Responsibilities
Leads and conducts complex audits as well as major regulatory inspections
Leads GxP due diligence activities
Works with contract personnel or consultants to prepare, conduct and report outsourced audits
Maintains and updates the audit management system
Leads training for QA colleagues and customers
Coaches and mentors QA staff
Leads the development and/or revision of QA processes and procedures including SOPs and risk assessment tools
Communicates effectively with compliance colleagues and customers
Promotes a culture of continuous improvement that focuses on delivering efficiencies and planned business benefits
Degree in a scientific discipline or qualified professional in compliance, law, regulations related to area of accountability
Significant experience in pharmaceuticals or a related industry
Excellent analytical, written and oral communication skills
Strong collaborative, partnering, and interpersonal skills
Strong ability to work independently
High ethical standards, trustworthy, operating with absolute discretion
Enhancing or Leading level of the following capabilities in the QA capability framework:
Influencing & Negotiating skills
Knowledge of Design and Conduct of Audits & Inspections
Regulatory Environment Insight
Active Management of Risks & Opportunities
Business Relationship Management
Demonstrated experience in managing global health authority inspections
Process Management and Continuous Improvement
If you are interested, apply now!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.