Senior Manager, Development Country Quality

Alexion; Mississauga; Hybrid; CAD 100,000 - 130,000; Full time

Job summary

A leading company in the field of rare disease research is seeking a Senior Manager for Development Country Quality in Mississauga. This role focuses on driving quality culture through engagements with teams while also managing strategic quality activities for clinical trials. The candidate will ensure compliance and lead inspections in a collaborative and innovative environment that values diverse contributions.

Qualifications

• 8+ years in clinical research, focusing on GCP/GxP compliance.
• Experience leading quality investigations and CAPA management.
• Ability to travel up to 20% when required.

Responsibilities

• Drive quality culture with Development and Regulatory stakeholders.
• Manage quality investigations and lead readiness for inspections.
• Identify quality and risk indicators for clinical trials.

Skills

Quality

Strong interpersonal skills

Critical thinking

Integrity

Communication

Teamwork

Problem solving

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

Senior Manager, Development Country 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 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.

You will be responsible for:

• Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs and/or countries assigned. Responsible to drive a culture of data and risk driven quality of clinical trials.
• 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 country 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 (local) for assigned programs/portfolio/countries 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.)
  • 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
• Support Due Diligence and integration activities as assigned

You will need to have:

• Bachelor’s degree in life science, or equivalent field, required
• Minimum of 8+ 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 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.

We would prefer for you to have:

• 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

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.