Position Summary

The position will manage and lead all aspects of ongoing Inspection Readiness for all of QC and QC readiness for scheduled internal and external audits. The position will manage and drive close-out of any commitments/actions from such audits. The position will work cross functionally within QC to support significant investigations and drive improvements.

Responsibilities:

• Ensure compliance with Alexion procedures and values
• Represent the QC department in internal and external audits.
• Lead the close out of actions/ recommendations identified from both internal and external audits and any compliance gaps identified within QC through investigations, risk assessments etc.
• Working cross functionally within QC to support significant investigations utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with other relevant departments and to support implementation of effective corrective and preventative actions.
• Represent QC and work across functions for ADMF Site Compliance projects such as Risk Register, Quality Bridges and other projects as required.
• Drive QC inputs for QMR.
• Keep management updated on issues and escalate as appropriate.
• Proactive engagement with Key stakeholders across the business.
• Represent QC at internal and external meetings in the absence of the QC Director
• Mentoring and training of QC staff as required.

Knowledge, Skills and Abilities

• Ability to develop collaborative relationships with other functions
• Excellent problem solving and root cause analysis skills.
• Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
• Excellent knowledge of systems and ability to use data analytics tools an advantage.
• Strongorganizationalskills.
• Planning/scheduling of own work and ability to delegate tasks where appropriate.
• Excellent written and oral communication skills.

Qualifications and Key Competencies

• Degree in chemistry or biological science or equivalent combination of education and experience.
• Minimum 7-10 years of laboratory experience in a GMP laboratory/manufacturing environment within the Pharma/Biotech industry.
• Proven ability to work in a matrixed organization.
• Project management skills required.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.