Director Country Operational Excellence
The Director Country Operational Excellence is responsible for driving a culture of data and risk driven operational excellence within the Clinical Operations Management (COM) group.
The Director Country Operational Excellence is responsible for providing leadership in quality-focused operational excellence to global COM and input and expertise to the regional and country level strategy and decision making in the area of inspection preparedness and readiness.
The Director Country Operational Excellence proactively determines global, regional and country level operations related Key Quality Indicators (KQIs) and develops mechanisms of KQI oversight and trending.
In consultation with cross-functional stakeholders and close collaboration with R&D Quality (RDQ) the Director Country Operational Excellence supports country operations-related audit and inspection management, Quality Event management and CAPA Plan development and execution to closure.
The Director Country Operational Excellence is recognized internally and externally as an innovative leader and expert within their area of specialization.
Job Duties & Responsibilities
Establishes and monitors a proactive, quality-driven operational excellence strategy within Country Operations, enabling the organisation to comply with and continuously improve within ICH GCP, local laws and regulations, as well as Alexion global processes in all COM countries.
Oversees the generation and maintenance of country operations business continuity plans
Proactively identifies and drives operational and quality improvement initiatives within COM and the Development Operations and Quantitative Science (DOQS) group
Provides quality expertise and process advice to COM group and its Leadership Team in coordination with the DOQS Operational Excellence (OpEx) group and RDQ
Maintains working knowledge of, and monitors new or changes to current international regulations, legislation, guidelines, and / or industry best practices, and provides input to possible changes to internal processes or ways of working, especially in the areas related to investigational sites and monitoring
Develops COM Procedural Documents that are compliant with global Procedural Documents and applicable international guidelines such as ICH GCP
In close cooperation with relevant partners, ensures excellence in the development and implementation of appropriate country operations-related processes, templates, guidelines, SOPs, tools and systems for successful clinical trial conduct;
ensures compliance with ICH GCP and other applicable regulations (e.g. CFR) and requirements
Successfully implementating global country operations-related processes and procedures to ensure relevant staff are aware of and proficient in the execution of those new processes and procedures
Provides operational leadership to the local implementation of systems and tools related to the delivery of clinical operational tasks or SOPs, ICH-GCP requirements, e.
g. CTMS, eTMF, Alexion University, Playbooks, reporting tools and dashboards, etc.
Proactively monitors, identifies, analyzes and manages global quality and compliance risks within COM
In collaboration with operational stakeholders and RDQ proactively develops effective and consistent quality risk mitigations to identified global risks and coordinates country risk mitigations activities, as applicable
Establishes, maintains, analyzes and acts on country operations Key Performance Indicators (KPIs) for continuous process and quality improvement and enables transparency and oversight of quality status to the Global Head of Clinical Operations
Collaborates with the RDQ team to ensure adequate country operations input to the R&D Audit Plan and strategy and to secure relevant support for investigator site inspections
Supports local country operations teams to ensure proactive identification and mitigation resolution of risks based on study / systems QC, audit and inspection outcomes
Drives and promotes a risk based, innovative approach to quality management
Coordinates Inspection Readiness activities across COM and promotes consistency within this area among all DOQS functions
Oversees and supports the process for COM related Quality Issue / Quality Event Management (including potential and confirmed Serious Breaches), inputs into CAPA Plan development, as required and supports execution to closure, including global trending and analysis.
Drives and promotes quality and compliance-focused continuous improvement initiatives and lessons learned within COM
Liaises and cooperates closely with relevant partners to ensure COM’s user requirements are met in all Alexion global systems and processes, and supports effective implementation in COM
Leadership & Collaboration
An active and participating member of the COM Leadership Team
Acts as an ad hoc advisory member of the RDQ / DOQS OpEx Leadership teams
Drives consistency and resolution of end-to-end quality challenges and opportunities in collaboration with other cross-functional stakeholders within and outside of DOQS to ensure COM alignment with strategic directions in quality areas
Implements a COM training strategy and maintains training plans to support high performance delivery in coordination with OpEx and ClinOps, as appropriate
Develops and supports an effective training network within COM and relevant R&D functions, to leverage the mutual sharing of locally developed training materials
Bachelor’s Degree or equivalent in life sciences or similar scientific subject
10+ years’ experience in Clinical Operations, Compliance or Quality Management
Sound knowledge of ICH-GCP and other relevant regulations
Understanding of quality by design, risk assessments, quality measures and metrics
High attention to detail and accuracy
Effective leadership skills
Excellent communication skills; fluent oral and written English
Positive attitude in managing change
Experience leading operational excellence initiatives
Experience in process improvement / management
Ability to collaborate with stakeholders in various functions
Good analytical, problem-solving and negotiation skills