Do you have expertise in, and passion for Quality? Would you like to apply your expertise influencing strategic directions on quality and compliance being the GVP/GCP expert related to clinical and post-market activities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

We are now recruiting for a Director Strategic Advice position to join our Strategic Advice team within R&D Quality Assurance. R&D QA is an independent global quality assurance function in AstraZeneca R&D maintaining the R&D Quality Management System and assessing quality based audits, inspections and self-reported quality issues. We promote and strive towards a state where everyone acknowledges that quality is a competitive advantage, and that quality arises from every individual’s contribution to a ‘right-from-me’ mentality. If you enjoy challenging the way things are done and want to pioneer a new future to meet global healthcare challenges this is the place for you.

This position is based out of our Gaithersburg, MD office and will follow a hybrid work schedule.

What you’ll do

• Work closely with stakeholders in R&D providing leadership in influencing strategic direction on quality and compliance through responsive and proactive GCP/GVP expert advice related to clinical and post-market activities including risk management.
• Deliver end-to-end regulatory inspection strategy and management.
• Manage business relationships with defined stakeholder groups and senior leaders in R&D, and for the strategic development and delivery of a GxP risk-based robust quality assurance program and quality management activities for these stakeholders.
• Lead or participate in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities, where applicable.
• Lead training for colleagues and business stakeholders.
• Support or lead the development and/or revision of QA processes, projects, and tools.
• Generate simple solutions to complex challenges while having a ‘solutions focused’ attitude.

Essential for the role

• Bachelor’s degree required, Master level degreed preferred
• 10+ years experience in pharmaceuticals or a related life-science industry required
• A thorough understanding and experience of GxP (GVP and GCP) and quality assurance/management
• Strong collaborative, influencing, and interpersonal skills, curious to understand business environment
• Excellent analytical, written and oral communications skills
• Proficient in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Skilled at managing & using technology, curious regarding AI
• Ability to maintain and create professional networks with stakeholders
• Experience in managing regulatory health authority GxP Inspections

Desirable for the role

• Project management
• Key Account management
• Experience in Six Sigma/Lean/Process improvement tools
• Quality and Audit expertise

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), anniversary awards, additional time off, pension plan, business travel insurance, recognition program, flexible working hours.

Why AstraZeneca?
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognize people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Interested? Come and join our journey.

Recognized thought leader in evolving data management trends, espousing a proactive approach to future-proofing data strategy.

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's Alexion division, you'll find an environment where innovation thrives alongside a commitment to making a difference for patients with rare diseases. Our entrepreneurial spirit combined with global resources creates a dynamic workplace where your career can flourish. You'll be part of a team that values diversity and inclusiveness while driving impactful change. With tailored development programs designed to enhance your skills and deepen your understanding of patient journeys, you'll be empowered to make meaningful contributions every day.

Ready to take on this exciting challenge? Apply now to join our team!

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