Director Product Quality

AstraZeneca plc; West Kirby; On-site; GBP 130,000 - 180,000; Full time

Benefits offered by this job

Hybrid work options

Career development program

Pension scheme

Job summary

You will lead the Quality Product Team, shape strategy, and ensure rigorous QA standards across all stages, collaborating with regulators and cross-functional partners worldwide.

Qualifications

• BS in biology, biochemistry, chemistry, engineering or related field.
• Experience in multiple areas of quality assurance within pharmaceutical manufacturing.
• QP eligibility or UK site license familiarity preferred.
• Strong leadership and interpersonal skills.
• Experience interacting with global regulatory bodies and knowledge of ICH, FDA, EMA, MHRA guidance.

Responsibilities

• Represent Quality on global teams and liaise across functions to protect patients and supply.
• Lead governance for Flu Franchise and drive timely information flow to CMC, Quality Product Teams, and site quality leads.
• Bridge communications between development, CMC, Quality, and Operations to remove barriers and ensure right-first-time outcomes.
• Engage with collaborators to implement CMC strategies and accelerate cycle times and robust product plans.
• Oversee end-to-end product insight from development to post-release events, linking control points to patient outcomes.
• Provide data-driven, phase-appropriate quality guidance to manage risk and enable confident decision-making.
• Review and approve regulatory filings to safeguard compliance and support global submissions.

Skills

Leadership

Quality Assurance

Regulatory Affairs

CMC Knowledge

Data-driven decisions

Education

BSc in related field

Advanced degree preferred

Job description

Are you ready to reinvent how Quality drives product excellence and patient impact? As Director Product Quality, you will lead the strategy and execution of quality across the full product lifecycle, with immediate influence on a high-profile franchise and a rich pipeline. You will accelerate our Lean evolution by using evidence, models, and data to make decisions that improve reliability, reduce risk, and get medicines to patients faster.

This role suits a decisive, science-led professional who can move seamlessly from policy to practice offering quick expert support to partners, building strong cross‑functional networks, and shaping development strategy. You will plan, coordinate, and implement scientific quality systems; analyze data trends to uncover risk and opportunity; and oversee initiatives that lift performance. Will you lead change and champion emerging technologies to raise the bar for quality and speed to patients?

Accountabilities:

• Enterprise Quality Leadership: Represent Quality on global teams, acting as the liaison for the entire Quality function for the Flu Franchise and other products, ensuring alignment and clear decision‑making that protects patients and supply.
• Flu Franchise Stewardship: Support the Flu Franchise governance team and drive effective information flow to CMC, Quality Product Teams, and site quality leads, translating strategy into phase‑appropriate execution.
• Cross‑Functional Integration: Act as the communication bridge between development, CMC, Quality, and Operations to remove barriers, synchronize priorities, and secure right‑first‑time outcomes.
• Strategy Enablement: Engage collaborators to implement CMC strategies and elevate Quality constraints early, enabling faster cycle times and robust product plans.
• End‑to‑End Product Insight: Maintain Quality understanding from cell and viral banking through post‑release events, connecting critical control points to patient outcomes.
• Risk‑Based Guidance: Provide data‑driven, phase‑appropriate Quality advice to the CMC Team to manage risk proactively and enable confident decision‑making.
• Regulatory Leadership: Review and approve regulatory filings as needed, safeguarding compliance and supporting successful submissions globally.
• Quality Product Team Leadership: Lead the Quality Product Team to resolve product quality challenges and capitalize on opportunities that strengthen robustness and supply.
• Standards and Procedures: Contribute to development procedures in your area of specialism and provide technical input into global standards to drive consistency and excellence.
• Continuous Improvement: Identify opportunities to enhance business processes and Quality systems, championing Lean ways of working that raise productivity and quality outcomes.
• External Influence: Participate in external engagement to shape CMC strategies and reflect best practice back into our standards.
• Coaching and Mentorship: Support and mentor colleagues across the wider Quality team, building capability and a culture of accountability and kindness.
• Bachelors of Science Degree in Biology, Biochemistry, Chemistry, Engineering or equivalent experience in related field
• Experience in multiple areas of quality assurance within a pharmaceutical manufacturing environment
• Confirmed work experience in Quality
• Strong leadership and interpersonal skills
• Experience interacting with global Regulatory Bodies
• Solid understanding and application of CMC related regulatory guidances (e.g., ICH, FDA, EMA, MHRA)
• Advanced degree in related field or equivalent experience preferred
• QP Eligibility, it would be preferential for the best candidate to be eligible to be named on our UK site license
• Understanding of egg‑based Flu manufacturing processes and analytics

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.

Why AstraZeneca:

Here, Quality is more than compliance it is a science‑led, patient‑first mindset that shapes every decision. You will work with ambitious colleagues who combine courage with kindness, putting unconventional combinations of experts together to spark bold ideas. With a diverse, fast‑moving pipeline and a sharp focus on scaling new technologies, you will apply digital models and Lean practices to anticipate risk, improve flow, and deliver medicines reliably and safely. Your influence will be visible, from certifying batches that reach patients to setting standards adopted across teams, all within a supportive community that values accountability, evidence, and continuous learning.

What is next?

Step into this pivotal role to shape how Quality fuels innovation and patient impact seize the opportunity to lead, learn, and create meaningful outcomes today!

We are looking forward to your application, not later than 12th November 2026