Director, Quality Operations

At Alexion, AstraZeneca Rare Disease, we are innovators, leaders, and collaborators. And at the heart of everything we do is an intense desire to pursue the toughest challenges and truly change the world for people living with rare and devastating diseases.

Introduction to role:

Are you ready to lead a team that ensures the highest standards of quality and compliance in clinical operations? As the Director of Quality Operations, you'll be a strategic partner to Product Development and Clinical Supply, guiding a team of professionals responsible for QA release of clinical finished products. Your leadership will be pivotal in maintaining the quality and compliance of clinical cGMP operations, including packaging, labelling, analytical sciences quality control, and more. Join us in driving excellence and innovation in quality management!

Accountabilities:

• Lead a team responsible for QA release and quality oversight of Clinical Finished Product and the Analytical Sciences Quality Control laboratory.

• Ensure patient safety and product quality through comprehensive quality oversight in compliance with Alexion’s quality management system and cGMP requirements.

• Translate strategic goals into tangible objectives for the team, removing obstacles and building capabilities.

• Champion lean thinking and drive continuous improvement initiatives to streamline processes and reduce waste.

• Implement risk management frameworks across cross-functional teams to drive accountability and lean compliance.

• Utilize digital tools for effective decision-making and guide resolution of significant issues using quality risk management methodologies.

• Proactively identify risks and define approaches for systemic reduction/removal, overseeing risk assessments and remediation plans.

• Track and report performance metrics, providing input on risk levels to senior management and proposing strategic interventions.

• Negotiate Quality Agreements with CMOs and CLOs.

• Maintain inspection readiness as Quality SME & lead for Health Authority inspections, internal audits, and external inspections.

• Promote AstraZeneca Culture and Values.

Essential Skills/Experience:

• 10 years + in a GMP role in the pharmaceutical industry, including experience with clinical phase I – III products and phase appropriate cGMPs.

• Bachelor’s degree in a scientific or technical field such as Pharmacy, Biology, or Chemistry; advanced degree a plus.

• Significant people management and development experience essential.

• Prior experience with IMP release, supply chain logistics, analytical quality control, and CXO oversight.

• Direct experience with HA inspections (FDA, EMA, HPRA or other authorities of similar standing).

• Demonstrated success in quality management and the resolution of technical challenges.

• Prior experience with quality oversight of combination products and/or cell & gene therapy products desired.

Desirable Skills/Experience:

• Demonstrated learning agility and a growth mindset.

• Ability to make decisions, solve problems, and manage ambiguity.

• Facilitate collaboration through open dialogue, information sharing, and conflict resolution within and across teams.

• Motivate and energize direct reports to achieve goals and engage in development.

• Expertise across multiple scientific disciplines to guide technical Quality evaluation and resolution of complex issues.

• Deep knowledge of regulatory requirements to provide strategic recommendations.

• Ability to navigate changing business priorities and manage setbacks effectively.

Life at Alexion:

We strive to be the most rewarding company to work for, fostering the type of environment that attracts and retains the best talent and provides the tools to enable each individual to perform at their personal best so that we maximize our collective impact. This means we:

• Empower team members to produce meaningful work through which they can see a connection to the patient

• Enable fulfilling work that maximizes their skills and potential

• Ensure team members feel valued by their managers as well as their colleagues

• Create a sense of belonging in our internal communities

• Optimize rewards and equity that recognize excellent contributions

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.

The duties of this role are generally conducted in an office environment. 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.

Ready to lead and inspire?

Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

Ready to make a difference? Apply now to join our team!

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