Director, Development Clinical 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.

The Role

As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory, and Safety partners. This involves learning, embedding a quality outlook, and delivering continuous improvement opportunities. You will manage business relationships with defined collaborator groups and senior leaders in Development, Regulatory, and Safety. You will also develop and deliver strategic, risk-based GCP quality management activities for these collaborators. Mentoring junior level team members to support team development.

Responsibilities:

• Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs and/or countries assigned.
• Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management
• Serve as the quality expert for global and local 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
  • Be accountable for leading inspection readiness global and local for assigned programs/portfolio/countries including but not limited to:
  • Provide leadership and guidance to study 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.)
  • Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/countries
• Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements
• Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
• Actively participate in meetings driving quality and business performance
• Participate in quality management reviews, risk reviews, and other clinical level quality reviews globally or locally. May lead country/regional specific quality reviews as assigned.
• Mentor and coach junior level team members
• Support Due Diligence and integration activities as assigned

Essential Qualifications:

• Bachelor’s degree in life science, or equivalent field, required
• Minimum of 12 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
• Experience participating in regulatory inspections
• Functional planning experience and ability to develop functional vision, priorities and tactics
• Experience with multinational products and regulations as well as with mandated risk management plans
• Ability to travel up to 20% or more as needed
• 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 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.

Desirable:

• Advanced degree preferred
• Competencies to be successful for this position include:
• Quality, process, and compliance oriented
• Strong interpersonal skills
• 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

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Annual base salary for this position ranges from 146,404.00 to 192,155.25.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.