Director, Strategic Advice- R&D Quality Assurance

1 month ago

Mississauga, Canada AstraZeneca Full time

Director Strategic Advice - R&D Quality Assurance

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking, and innovation – ultimately providing employees with the opportunity to work across teams, functions, and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm, and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet, and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

This is what you will do:

As the independent second line R&D quality assurance function, partner with collaborators in R&D and provide leadership in influencing strategic direction on quality and compliance through responsive and proactive GxP expert advice related to clinical activities. This will include effective compliance reporting to senior management and relevant quality governance forums.

Investigate critical Quality Issues as well as deliver end-to-end regulatory inspection strategy and management. We’re looking for people driven by making a difference to patients and society, dedicated to doing the right thing.

With that in mind, the role is best suited to candidates with a high degree of integrity and critical thinking agility. It is also important to have a ‘solutions-focused’ demeanor and the ability to generate simple solutions to complex challenges. Importantly, you will need to have a proactive ‘Business Partnering’ approach and the personal credibility to effectively communicate and establish trust with senior partners and leadership teams across the globe. This is critical to enable you to influence decisions and thereby sustain the Quality Attitude.

Having strong collaborative, influencing, and interpersonal skills and being curious and willing to understand the business environment is crucial.

You will be responsible for:

Business Partnering

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

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

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

You will need to have:
  • Degree level education.
  • Significant experience in pharmaceuticals, biotechnology, or a related industry
  • A thorough understanding and experience of GxP and quality assurance/management
  • Working knowledge of GCP/GVP and health authority regulations and guidelines (e.g., MHRA, EMA, FDA, PMDA)
  • Excellent analytical, written, and oral communications skills
  • High ethical standards, trustworthy, operating with absolute discretion
  • Strong collaborative, influencing, and interpersonal skills – curious to understand the business environment
  • Skilled at managing and using technology
  • Ability to maintain and build professional networks
  • Experience in managing regulatory health authority GxP Inspections

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
  • Experience in digitalization

Great People want to Work with us Find out why:

Are you interested in working at AZ? Apply today

Why AstraZeneca?
At AstraZeneca, you will be valued. Not only for your unique contribution, skills, and background, but because we recognize people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition, and bright minds, there’s no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Interested? Come and join our journey.

Date Posted: 31-Jul-2024

Closing Date: 22-Aug-2024

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. #J-18808-Ljbffr

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