Director of Pharmaceutical Quality System (PQS)

Introduction to role:

Are you ready to lead the charge in pharmaceutical quality systems? As the Director of Pharmaceutical Quality System (PQS), you will provide strategic leadership and oversight within our Development organization. This pivotal role demands advanced scientific acumen, comprehensive regulatory knowledge, and exemplary leadership to ensure our quality systems consistently meet rigorous standards. You'll be at the forefront of enhancing PQS processes, driving innovation, and ensuring excellence in everything we do.

Accountabilities:

• Provide leadership of quality systems.

• Lead the design, implementation, and maintenance of pharmaceutical quality systems, ensuring alignment with global regulatory requirements including GMP, ICH, FDA, and EMA. Serve as the key contact into Operations PQS.

• Manage the quality business processes, support regional process champions (RPCs), and establish clear standards for effective process management and continuous improvement initiatives.

• Act as a mentor to PQS RPCs and assume the RPC role for selected quality processes as needed. Motivates and guides teams through transformation initiatives, fostering a culture of excellence and continuous improvement.

• Oversee the collection, visualisation, and reporting of quality metrics, ensuring senior management has access to critical data for informed decision-making.

• Represent the Head of Development Quality in leading regional management reviews and serve as the Management Review RPC.

• Work with Accountable Quality Site Leads to uphold Licence to Operate (LTO) requirements through diligent monitoring of relevant metrics.

• Adept at developing and implementing long-term quality strategies aligned with organisational goals and regulatory frameworks.

Essential Skills/Experience:

• Bachelor’s degree or equivalent experience in an appropriate subject area.
• Substantial experience working within a pharmaceutical GMP environment, ideally within pharmaceutical development organisations.
• Proven background in Quality Assurance Management, with thorough expertise in Quality Systems and GMP or related GXP areas.
• Eligibility for Qualified Person (QP) status preferred.
• Extensive understanding of the pharmaceutical and drug development lifecycle.
• Recognised expertise and authority in Quality Assurance, particularly regarding GMP compliance.
• Confident engaging partners at all organisational levels and navigating complex matrix environments

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 we need 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.

At AstraZeneca, we are driven by a relentless pursuit of excellence. Our commitment to innovation means we are constantly searching for opportunities to add value and improve outcomes for patients. With a focus on science and evidence-based decision-making, we empower our teams to foresee risks and act swiftly. Here, you'll find a collaborative environment where each voice matters, fostering camaraderie and shared knowledge. Our inclusive community encourages growth and offers exposure to exciting new products and technologies. Join us as we continue to make a real-life difference for patients worldwide.

Ready to make an impact? Apply now and become part of our journey towards excellence!

Date Posted

03-out.-2025

Closing Date

17-out.-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.