Associate Director, Clinical Development and Operations Quality

This is what you will do:

• Under the direction of Director, Quality Lead for Clinical Development Country Operations, the Associate Director, Quality Operations Lead (AD, QOL) is accountable as Clinical Operations Management (COM) quality support and is responsible for driving a culture of data and risk driven quality oversight of the clinical trials. The AD, QOL is responsible for providing quality-focused leadership for execution of Rare Disease Business Unit at the country and site level.
• The Associate Director, Quality Operations Lead (AD, QOL) is responsible for active engagement with Country Operations Team to support a culture of sustainable regulatory compliance at country and site level via the risk-based quality management principles within and across portfolio. The AD, QOL will be responsible for proactive process efficiencies’ assessment and building remediation/optimization in partnership with business process owners and COM organization as applicable.
• The AD, Country level QOL will act as clinical compliance advisor/partner to the COM team. This role will work closely with COM Team and and Study QOLs to proactively identify country level Key Quality Indicators (KQIs) and develops mechanisms of KQI oversight and trending.
• This role will collaborate closely with Study Quality QOLs and risk/issue owners to assure systemic and systematic risks and issues are communicated in a timely manner to be managed through action and resolution.
You will be responsible for:
• In alignment with Director Clinical Development and Operations Quality, the
AD, Country QOL supports development of an overarching strategy related to
proactive and sustainable quality and compliance for all programs/portfolio
across all Therapeutic Area(s) (TAs) at country level.
• Provide Quality advice to Clinical Operations Management (COM) group
globally related to GCP compliance of COM processes and their continuous
improvements.
• The CQOL is responsible for the development, implementation and
continuous review of local procedural documents, and maintains current
knowledge and understanding of local regulations and industry practices in
relation to clinical trials.
• Provide advice to Local Study Teams on procedural framework including
global clinical processes, procedural documents, applicable Quality &
Compliance manual documents, and on international guidelines such as ICHGCP,
industry standards and local regulations.
• Support local management in the planning and conduct of local quality
control activities including but not limited to performing accompanied site
visits. Performs any required QC visits / QC activities with local staff and
maintains the annual quality plan updated.
• Work closely with COM team and other quality partners to proactively identify
country level Key Quality Indicators (KQIs). Develops mechanisms of KQI
oversight and trending. Provide local COM with information regarding status
of quality issues and quality trends observed in COM.
• Collaborate with other quality representatives and supports local study teams
to resolve quality and compliance issues.
• Review regularly Protocol Deviations and ensures Quality Issues are reported
within the appropriate timelines to local Authorities and in internal review
systems according to QI process.
• Support the local organisation in the preparation for, conduct of and
responses to audits and regulatory inspections.
• Give regular feedback and Lessons Learned on audit and inspection findings
to relevant COM and regional/ global CQ network.
• Identify and ensure resolution of potential risks based on previous
study/systems QC results, audit and inspection results and current routine
quality management work.
• Identify and organise/provide on-going and ad hoc training of local staff
according to local training needs, in cooperation with local COM leadership:
o introductory training to new staff, including Procedural Training,
o ad hoc local training solutions e.g., as result of serious or recurring
quality issues.

You will need to have:
• Bachelor’s degree in life science, or equivalent field, required.
• Minimum of 8-10 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.
• Experience in managing, mentoring and directing people.
• Ability to travel up to 20% or more as needed.
We would prefer for you to have:
• Advanced degree preferred
• Competencies to be successful for this position include:
• Quality, process, and compliance oriented
• Strong interpersonal skills
• Critical thinking
• Integrity
• Communication
• Teamwork
• Problem solving

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.