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Associate Director Risk Based Quality Management
3 months ago
Job Title: Associate Director Risk Based Quality Management
Introduction to Role:
Are you ready to explore rare opportunities in the forefront of biomedical science? We are seeking an Associate Director, Risk based Quality Management (RbQM) to drive the RbQM process in assigned studies or projects. This role ensures compliance with ICH-GCP R2, Guidelines and SOPs, safeguarding clinical trial integrity and patient safety. You will work closely with Global Project and Study teams, Senior Specialists RbQM and Clinical Data Scientists at the initial stages of the studies. Your role involves overseeing various tasks and implementing process improvements to ensure an integrated cross-functional approach to managing quality in clinical study conduct.
Accountabilities:
As an Associate Director, you will lead the RbQM process and centralized monitoring in eligible studies. You will engage and collaborate with project teams during initial stages of studies to implement a Quality by Design (QbD) approach. You will act as a subject matter expert (SME) in the area of RbQM and risk management both internally and externally. You will also oversee activities performed by more junior RBQM team members and lead the development of CM methodology and CM best practices.
Essential Skills/Experience:
- Minimum of a BSc degree in Life Science with a minimum of 8-10+ years of experience in the Biotech/Pharma/CRO industry
- A minimum of 3 years of experience in Risk Based Quality Management or highly transferrable skillset from a related field in Clinical Development.
- Deep understanding of the clinical development and risk based monitoring and Centralised monitoring methodologies.
- Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management.
- Excellent communication skills in both written and spoken English.
- Strong Project Management and Risk Management skills.
- Ability to mentor, train and lead teams in projects.
- Responsiveness to industry and business needs and embracing peers’ review.
- Demonstrates strong cross-functional leadership skills.
- Ability to operate in an professional environment that can be volatile, uncertain, complex and ambiguous.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
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.
Joining Alexion, AstraZeneca, Rare Disease means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit and autonomy of a leading biotech. You’ll join an energizing and kind culture where people build connections to explore new ideas and learn.
Ready to make a difference where it truly counts? Apply now
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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