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Associate Quality Director EMEA

Job Details

Job Description

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the most serious diseases. But we’re more than a leading pharmaceutical company.

Make a more meaningful impact on lives around the globe

Here you’ll have the chance to create a meaningful difference in patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes, and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

Are you a leader with an eye for continuous improvement? Are you also a problem solver who is used to working cross-functional within the Quality field? Then your future start with us!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Business Area

External Quality provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations. The scope of the organization includes outsourced API, Biologics CMOS, Direct Materials, Formulation and Packing CMOS, Critical General Services, Contract Laboratories, Certification of Materials, and the global IT System for Supplier Management.

External Quality is now looking for an Associate Quality Director in the EMEA region to lead the Direct Materials Team. You will be responsible for a team of approx. 10-15 Quality Supplier Manager. This role can be located both in Södertälje or Macclesfield.

What you’ll do

The Associate Quality Director is responsible for the leadership of the EMEA Direct Material Supply (DMS) Quality Assurance organization, partnering with Procurement to ensure seamless delivery of Direct Materials to our customer base across both large and small molecule supply. The job holder is a member of the Extended External Quality Leadership team and includes line management of Quality professionals predominantly located within the EMEA region.

You will be accountable for ensuring a high level of Quality System performance of activities such as change control, complaint and deviation investigations, quality issue management and escalation, QA Agreements, and Supplier Quality Assessments within the region. You will also work closely with External Quality and Procurement professionals to drive standardization and continuous improvement across the DMS supply chain.

Main responsibilities:

• Line manage a team of 10 – 15 Supplier Managers
• Provide and/or coordinate training and coaching
• Ensure compliance with GMP and Regulatory requirements by providing accurate coaching, mentoring, and consultation to the team
• Make decisions and advise the External Quality team regarding quality and pharmaceutical technology issues within your area of expertise
• Perform the Quality review and/or approval of cGMP documentation for your area
• Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Supervise internal/external factors such as emerging regulations or shifts in regulatory enforcement
• Responsible for quality issues escalation and resolution at the Suppliers, to ensure the right product at the right time is delivered into the Product Supply Chain

Essential for the role

• Bachelor’s degree in a science / technical field
• Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development, and execution, and other evolving principles across the global compliance arena.
• Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
• Self-directed and highly motivated teammate with solid organizational capabilities
• Cross-cultural awareness and sensitivity
• Knowledge and experience in Business Process Management and how to apply LEAN methods and tools
• Excellent written and verbal communication skills, with an ability to manage stressful and confrontational situations to positive outcomes
• Awareness of related functional areas such as product development

To be successful in this role you need strong problem-solving, negotiating, and influencing skills. An ability to work independently under your own initiative is also required. You have experience working cross-functionally and managing significant improvement initiatives. You need to be able to travel nationally and internationally approximately 25% of your time, of course, planned well in advance.