［Alexion Korea］Associate Director, Development Country Quality
This is what you will do:
- Under the direction of Director Development Country Quality, the Associate Director Development Country Quality (AD DCQ) 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 DCQ is responsible for providing quality-focused leadership for execution of Rare Disease Business Unit at the country and site level.
- The Associate Director Development Country Quality (AD DCQ) 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 DCQ 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 DCQ will act as clinical compliance advisor/partner to the COM team. This role will work closely with COM Team and and Study DQAs 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 DAQs 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 Development Country Quality, the AD DCQ 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 AD DCQ 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 ICH-GCP, 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. Oversees and supports 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.
- 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 quality 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:
- introductory training to new staff, including Procedural Training,
- 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
- Problem solving
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.