Senior Manager, Development Asset Quality

SENIOR MANAGER, DEVELOPMENT ASSET QUALITY

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

As a member of the Development Quality Team, you will work together with colleagues from the Development, Regulatory, and Safety departments to cultivate a culture of excellence. This includes acquiring knowledge, adopting a focus on quality, and driving continuous improvement efforts. Your role will involve supporting business relationships with specific collaborator groups in Development, Regulatory, and Safety. You will also be responsible for delivering risk-based GCP quality management activities for these collaborators.

RESPONSIBILITIES:

• Support the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)
• Collaborate with various teams to identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develop methods for their detection, oversight, and trending. This includes working with colleagues in Clinical Development, Operations, and other relevant functions.
• Support global/systemic clinical quality issue investigations, which includes:
  • In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
  • Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs.
  • Acts as quality approver for Quality Issues and CAPAs as assigned.
• Support inspection readiness for assigned programs/portfolio including but not limited to:
  • Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance.
  • Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)
  • Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
• Support continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues.
• Support in meetings driving quality and business performance.

ESSENTIAL SKILLS:

• Bachelor’s degree in life science, or equivalent field, required.
• Minimum of 6+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.
• Established knowledge of GCP regulations and guidelines (EMA, FDA, PMDA etc.)
• Experience participating in regulatory inspections.
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment.
• Ability to maintain and build professional networks with collaborators.
• Excellent communication skills; fluent oral and written English

DESIRABLE SKILLS:

• Preference given to candidates with an advanced degree or equivalent experience.
• Competencies to be successful for this position include:
• Quality, process, and compliance oriented

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

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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.