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.
Ready to make a difference? Apply today!
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