Director Strategic Advice R&D Quality Assurance

Join us at AstraZeneca, a global biopharmaceutical company with a focus on innovation and collaboration. We are currently seeking a Director of Strategic Advice for our R&D Quality Assurance team. This role is based in our Gaithersburg MD offices, designed to foster collaboration and innovation. Our commitment to sustainability and tackling global health challenges makes AstraZeneca a fulfilling place to work.

In this role, you will be responsible for providing leadership and strategic direction on quality and compliance related to clinical activities. As the independent second line R&D quality assurance function, you will partner with stakeholders in R&D and provide leadership in influencing strategic direction on quality and compliance. You will investigate critical Quality Issues and deliver end-to-end regulatory inspection strategy and management. This role requires a high degree of integrity, strategic thinking, agility, a ‘solutions focused’ attitude, and the ability to generate simple solutions to complex challenges.

Business Partnering

• Leading strategic direction of good clinical practice (GCP) and/or good pharmacovigilance practice (GVP) quality and compliance through engagement with defined customer groups.
• Providing effective compliance reporting to senior management and supports strategic QA governance forums.
• Supporting quality and compliance risk management for collaborator groups.

Inspection

• Providing QA oversight and leadership for managing regulatory GCP/GVP inspections.
• Delivery of end-to-end GCP/GVP inspection strategy for key regulatory authority inspections

CAPA

• Leading or participating in the investigation of critical quality issues and ensures timely reporting of issues to relevant authorities.
• Supervising significant CAPAs for activities in R&D.

Essential Skills/Experience:

• A B.S. Degree in Biology or related STEM field.
• 5 plus years’ experience in pharmaceuticals, biotechnology, or a related industry.
• A thorough understanding and experience of GxP and quality assurance/management.
• Working knowledge of GCP/GVP and health authority regulations and guidelines (e.g., MHRA, EMA, FDA, PMDA.)
• Excellent analytical, written, and oral communications skills.
• High ethical standards, trustworthy, operating with absolute discretion.
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment.
• Skilled at managing and using technology.
• Ability to maintain and build professional networks.
• Experience in managing regulatory health authority GxP Inspections.

Desirable Skills/Experience:

• Project management experience.
• Knowledge of six sigma/lean/process improvement tools.
• Audit expertise.
• Understanding of Quality Management Systems.
• Experience in digitalization.

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 follow the science to explore and innovate. We are driven by our desire to understand and reveal new insights into the world's most complex diseases. Our inclusive environment encourages creativity and resilience, allowing us to push the boundaries of science to deliver life-changing medicines. We are committed to making an impact on patients' lives globally and improving access to healthcare. If you are passionate about science and want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.

Ready to make a difference? Apply today!

Date Posted

23-Sep-2024

Closing Date

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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.