Senior Director, Development Clinical Quality (Americas)

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.

This is what you will do:

As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities.  You will be responsible for managing business relationships with defined stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GCP risk based robust quality management activities for these stakeholders. The Sr. Director will be responsible for managing a team of clinical quality business partners including but not limited to providing mentoring, coaching, development, and resource management, etc.

You will be responsible for:

• As a member of the DQA Leadership team, actively shape the DQA organisation’s remit:

  • Lead a team of clinical quality business partners

  • Accountable for development of assigned staff and achievement of performance standards, capability and effective organizational leadership

  • Optimise the business performance of direct reports to ensure an effective DQA organization

  • Contributes to functional budget management, including Co2.

  • Ensure adequate resource management and utilization.

• Provides quality expertise related to regulatory inspection support strategy, oversight and response and interacts with relevant regulatory authorities.

• Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable.

• Lead or participate in functional quality management reviews, risk reviews, and other Global/Country level quality reviews, as assigned.

• Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues.

• Lead meetings driving quality and business performance, partner with stakeholders in Development, Regulatory and Safety in driving Quality culture and Quality mindset

• Lead Due Diligence and integration activities, as assigned.

You will need to have:

• Bachelor’s degree in life science, or equivalent field, required. Advanced degree preferred

• 15+ 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 GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)

• Significant experience with GxP investigations, risk assessments and CAPA management.

• Significant experience in managing regulatory health authority GxP Inspections

• Functional planning experience and ability to develop functional vision, priorities and tactics.

• Strong collaborative, influencing and interpersonal skills – curious to understand business environment

• Experience in managing, mentoring and directing people.

• Ability to travel up to 10%.

• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

• Competencies to be successful for this position include:

  • Quality, process, and compliance oriented

  • Critical thinking

  • Integrity

  • Communication

  • Teamwork

  • Problem solving

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.

#LI-Hybrid

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.