Director Strategic Advice - R&D Quality Assurance

AstraZeneca•Gaithersburg, MD

13d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.