Clinical Quality Associate Director (6 - Month Secondment)

Role Summary

The Clinical Quality Associate Director (6 - Month Secondment) is the first point of contact on quality and compliance matters for the Oncology Site Management and Monitoring (SMM) function. They develop, track and analyze quality metrics at country level and provide guidance on applying GCP principles to SMM Oncology personnel to ensure high-quality clinical trial delivery.

Responsibilities

• Support the execution of the LDO Clinical Operations Quality Framework as the first point of contact on quality and compliance matters to the SMM Oncology Country teams for high-quality clinical trial delivery.
• Drive strategic focus on quality for the Oncology portfolio, in collaboration with other AZ compliance-supporting functions. Draft local country quality plans and manage the finalized/approved annual country quality control plan.
• Ensure adherence to GCPs and LDO Clinical Operations objectives, including managing and maintaining country-specific procedures and guidelines.
• Assess the training compliance of local SMM teams as part of quality oversight. Provide onboarding training on quality and compliance topics for local SMM teams. Conduct ad hoc training to address identified gaps in quality compliance. Share global process updates impacting local SMM team quality compliance in a timely manner.
• Facilitate the resolution of compliance issues and promote adoption of best practices within SMM Oncology countries. Support investigations and approve reported quality events and CAPAs in Veeva Quality Vault (VQV), if applicable.
• Foster a quality culture in SMM Oncology. Develop and implement compliance improvement recommendations, initiatives, and plans. Provide country-level consultation during RIST, inspections, and audits. Potentially serve as an audit coordinator for AZ internal audits and contribute as a SME during sponsor and investigator site inspections. Provide consultation for inspection responses.
• Provide insights from quality metrics and issue trending at the local country level to improve investigative performance and proactive issues management.
• Participate in the local country SMM leadership team. Support quality review meetings with SMM Oncology leadership and other stakeholders. Identify, calibrate, and track compliance risks; manage risk registers and the risk management plan with country SMM leadership.
• Collaborate with the DQM, other quality functions, and stakeholders in the LDO Clinical Operations Quality Network to seek sustainable issue resolutions.
• Assess the need to conduct quality site visits in line with the country quality plan and perform site visits as part of annual quality control activities, based on site-level risks.
• Seek opportunities for improvement and knowledge sharing from audits and inspections to foster cross-learning.

Qualifications

• Undergraduate degree in life sciences or an equivalent related discipline.
• In-depth knowledge and broad experience within the pharmaceutical (biopharma) industry in a GxP regulated environment.
• Excellent communication skills with the ability to network cross-functionally and globally.
• Critical thinking, influencing and communication skills.
• Ability to collaborate, network and interact at all levels.
• Strong risk-based decision-making skills.
• Excellent understanding of the drug development process and related GXP activities.
• Excellent understanding of the skills and knowledge required for successful delivery of a clinical study (e.g., ICH-GCP, study management).
• Excellent knowledge of international regulations and guidelines, as well as AZ Procedural Framework.
• Analytical, problem-solving, negotiation and conflict resolution skills. Ability to multi-task.
• Ability to set and manage priorities, performance targets and projects in a global environment.
• Ability to collaborate proactively, handle ambiguity, build strong customer relationships and strategic partnerships to harmonize and standardize processes and systems.

Desirable Skills

• Advanced degree in life sciences or an equivalent related discipline.
• Experience working with global and remote cross-functional teams.
• Ability to work in an environment of remote collaborators.
• Expert reputation within the business and industry.
• Good cultural awareness.

Education

• Undergraduate degree in life sciences or an equivalent related discipline.
• Desirable: Advanced degree in life sciences or an equivalent related discipline.