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.  

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.