Associate Director, Development Quality Risk Strategy
This is what you will do:
As part of the Development Quality Team you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GXP risk based robust quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management.
You will be responsible for:
- Supports strategic direction on quality and compliance risk in R&D.
- Partner with business units to ensure consistency in risk management and adoption of risk-based thinking. Embedding risk quality culture within the business.
- Guide the ARDU risk culture evolution alongside AstraZeneca (AZ) colleagues, coaching shared ways of working and best practices across ARDU and the AZ network.
- Assist with the identification of potential systemic gaps and develop and propose remediation plans for global and / or cross-functional implementation.
- Conduct analysis of risk assessments and rankings and develop risk analytics and reporting dashboards to support Management Reviews and inform decision making.
- Provides responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert.
- Provides effective compliance risk reporting to senior management and supports strategic quality governance forums
- Apply proactive risk management principles to strategic projects and other complex initiatives lead by Development Quality.
- Supports Due Diligence activities as assigned.
Provides Development Quality oversight and leadership for the management of regulatory GxP inspections
- Leads or participates in the investigation of critical clinical quality issues and ensures timely reporting of issues to relevant authorities
- Oversees significant CAPAs for clinical activities in Development, Regulatory and Safety
- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
- Communicates effectively with Development Quality colleagues and business stakeholders
- Maintains knowledge of relevant industry information affecting quality and compliance arena
- Leads training for colleagues and business stakeholders as required.
- Involved in and may lead the development and/or revision of Development Quality processes, projects and tools
You will need to have:
- Bachelor’s or Higher Degree in life sciences or similar scientific subject
- Significant experience in pharmaceuticals, 8+ years experience in the R&D quality assurance area
- Strong collaborative, influencing and interpersonal skills – curious to understand business environment
- Ability to maintain and create professional networks with stakeholders
- Experience in managing regulatory health authority GxP Inspections
- High attention to detail and accuracy
- High ethical standards, trustworthy, operating with absolute discretion
- Effective leadership skills
- Excellent communication skills; fluent oral and written English
We would prefer for you to have:
- Good analytical, problem-solving and negotiation skills
- Experience in working in a global role
- Cultural Awareness and Positive attitude in managing change
- Project Management experience
- Audit expertise
- Prior experience in quality risk management strategies in R&D
- Quality Management