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alexion

Director, Strategic Advice

Location: Mississauga, Canada Job reference: R-191845 Date posted: 02/09/2024

This is what you will do:

As the independent second line R&D quality assurance function for our mission is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The job holder is responsible for managing business relationships with defined stakeholder groups and senior leaders in R&D and for the strategic development and delivery of a GXP risk-based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management.

You will be responsible for:

Business Partnering

  • Leading strategic direction of good pharmacovigilance practice (GVP)/good clinical practice (GCP) quality and compliance through engagement with defined stakeholder groups
  • Providing responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GVP/GCP expert
  • Providing effective compliance reporting to senior management and supports strategic QA governance forums
  • Supporting quality and compliance risk management for stakeholder groups
  • Supporting Due Diligence activities as assigned

Inspection

  • Providing QA oversight and leadership for regulatory GVP/GCP inspections
  • Delivery of end-to-end GVP/GCP inspection strategy for key regulatory authority inspections
  • Providing general support related to GxP regulatory authority inspections locally/globally as and when required

CAPA

  • Leading or participating in the investigation of GVP/GCP critical quality issues and ensures timely reporting of issues to relevant authorities
  • Overseeing significant CAPAs for pharmacovigilance activities in R&D

General Accountabilities

  • Ensuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs, and guidelines
  • Promoting a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
  • Communicating effectively with QA colleagues and business stakeholders
  • Maintaining knowledge of relevant industry information affecting quality and compliance arena
  • Leading training for colleagues and business stakeholders as required.
  • Involved in and may lead the development and/or revision of QA processes, projects, and tools
  • Coaching and mentoring QA colleagues

You will need to have:

  • Bachelor’s degree in life science required. Advanced degree strongly preferred.
  • Significant experience in pharmaceuticals, biotechnology, or a related industry
  • Working knowledge of GVP/GCP and health authority regulations and guidelines (e.g., MHRA, EMA, FDA, PMDA) pertaining to pharmacovigilance
  • Excellent analytical, written, and oral communications skills
  • Fluent in written and spoken English
  • High ethical standards, trustworthy, operating with absolute discretion
  • Strong collaborative, influencing and interpersonal skills – curious to understand business environment
  • Skilled at managing and using technology
  • Ability to maintain and create professional networks with stakeholders
  • Experience in managing regulatory health authority GxP Inspections
  • 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:

  • Project management experience
  • Knowledge of six sigma/lean/process improvement tools
  • Audit expertise
  • Understanding of Quality Management Systems

#Li-Hybrid

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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.

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