Quality Manager- Complaints Jobs

At AstraZeneca, we strive to continuously meet the unmet needs of patients 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.

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines

The Quality Manager (QM) is responsible for the Quality compliance activities for External Quality (EQ) supply chains and suppliers such as complaints. You will be assigned key areas of responsibility, but will be trained in the other areas of the quality system to help support the rest of the team during times of peak workload or holiday coverage.

This position assesses, investigates and trends product complaints of pharmaceuticals and

combination products. The root cause investigations include visual and functional inspection of

returned product and correspondence with other departments and suppliers.

The role of Quality manager involves a balance between the cross-functional collaboration and at the same time be able to act with integrity. You have independent tasks and in your role must be able to both make and contribute to quick decisions. This requires you to be structured, flexible and responsible. You have good leadership skills and communicate clearly and pedagogically in both speech and writing with people in several different roles.

What you'll do

Complaints Management –

• Support EQ Quality Management Systems
• Conduct and coordinate root cause analysis for product complaints.
• Escalate critical product complaints or issues to management.
• Support audits and inspection requests for sites
• Processes within a functional area.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or
• Facilitate process and system improvements
• Receipt, triage and investigation of product complaints,
• Correspond with investigating departments and suppliers to ensure adequate and
• Complete investigations.
• Visual and Functional investigation of pharmaceutical and Combination Product device constituents with possible biohazardous contamination, while following all universal precautions.

Essential for the role

• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
• 2 years Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
• Ability to travel nationally and internationally as required approximately 10% of your time.
• Strong negotiating/influencing skills
• Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
• Strong problem solving skills
• Master degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country).

Desirable for the role

• Experience working in a PCO/PET organization
• Proven experience in Quality Assurance or combination of Quality and Technical
• Multi-site / multi-functional experience
• Lean/Six Sigma training.

Why AstraZeneca

When we at AstraZeneca see the chance to change, we take this opportunity - for every opportunity, no matter how small, can be the beginning of something big. We are therefore looking for you, who together with your team will make a difference for patients' lives every day. We at AstraZeneca welcome your positive attitude and your desire to develop both yourself and your team. You will get use for your drive and your ability to work carefully and structured even at a high tempo.