[Alexion] Associate Director, Development Clinical Quality

[Key Accountabilities]

• 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 o continuous improvement opportunities. You will be responsible for managing business relationships and delivery of a GCP risk based robust quality management activities. Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/studies at a country level.  

• Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending.

• Serve as the quality expert for Quality Events at a country/ regional (if needed).

• Be accountable for leading inspection readiness at local level and providing input to global inspection readiness.

• Supporting local/ global teams (if needed) on risk-based approach in implementation of current routine quality management work. 

• Provide advice to local/ global (if needed) teams to ensure that processes and procedures are compliant with AZ procedures, international GXP requirements and relevant legal regulations. 

[Qualifications]

• Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance 

• Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)  

• Significant experience with GxP investigations, risk assessments and CAPA management 

• Experience participating in regulatory inspections 

• Functional planning experience and ability to develop functional vision, priorities and tactics 

• Experience with multinational products and regulations as well as with mandated risk management plans 

• Ability to travel up to 20% or more as needed 

• 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.