Clinical Quality Associate Director (LDO CQAD), Late Development Oncology, Clinical Operations (m/f/d)

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The CQAD is the first point of contact on quality and compliance matters for the Oncology Site Management and Monitoring (SMM) function. They are responsible for developing, tracking and analyzing quality metrics at country level.  They provide direction and advice on how to apply GCP principles to SMM Oncology personnel so that their work can be conducted while meeting high quality standards.

The CQAD utilizes regulatory guidance, global standards and SOPs to provide compliance advice to SMM Oncology. When appropriate, the CQAD recommends and communicates improvement opportunities to the Business Process & System Owners (BPOs).  CQADs supports SMM Oncology management by consulting on compliance learning needs and delivery.

The SMM Oncology country leadership team keeps overall accountability of quality. The CQAD role holder ensures appropriate and close collaboration and communication with the SMM Oncology country leadership team and other functions for planning and implementing quality control activities.

The CQAD reports directly to the respective Director of Quality Management (DQM) within their HUB or region. The close collaboration and continuous informational exchange between CQAD and DQM ensure that identified quality trends, flagged issues, and relevant mitigations/ solutions are effectively synchronized across countries and regions. In addition, areas of involvement on a cross country/Hub and process level are actively supported through DQM involvement upon notification.

Main Responsibilities:

Main responsibilities of an CQAD include:

• 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. Responsible for drafting local country quality plan and managing 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 activities. Provide onboarding training on quality and compliance topics for local SMM teams. Conduct ad hoc training to address any 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 the adoption and sharing of best practices and learning within SMM Oncology countries. This includes supporting investigations and approving reported quality events and corrective and preventive actions (CAPAs) in Veeva Quality Vault (VQV), if applicable.

• Play a significant role in fostering an engaging quality culture in SMM Oncology. Develop and implement compliance improvement recommendations, initiatives, and plans. Offer country-level consultation for SMM Oncology and/or LDO Clinical Operations during RIST, inspections, and audits. Potentially serve as an audit coordinator for AZ internal audits (site and project) and contribute as a subject matter expert (SME) for AZ SMM quality processes (both global and local) during sponsor and investigator site inspections. Act as a key member throughout the entire site and sponsor inspection process, including providing consultation for inspection responses.

• Provide insights and interpretations from identifying, developing, or analyzing quality metrics including quality issue trending at the local country level, aiming to improve investigative performance and proactive issues management.

• Participate as a member of the local country SMM leadership team. Support the facilitation and delivery of quality review meetings with SMM Oncology leadership or other stakeholders. Contribute to identifying, calibrating, and tracking compliance risks, escalating as required, and defining or supporting risk mitigation activities. Facilitate country quality risk registers and manage the risk management plan with the country SMM leadership.

• Collaborate actively with the respective 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 accordance with the country quality plan. Perform quality site visits as part of annual country quality control plan activities, if applicable, based on risks identified at the site level.

• Continually seek opportunities for improvement and feedback from SMM Oncology leadership and LDO Clinical Operations personnel, fostering a culture of knowledge sharing and cross learning (e.g., learnings from audits and inspections).

Education, Qualifications, Skills, and Experience:

Essential:

• 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 a proven ability to effectively network cross functionally and globally.

• Critical thinking, influencing and communication skills.

• Ability to collaborate, network and interact widely and effectively 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 the 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

• Good analytical, problem solving, negotiation and conflict resolution skills. Ability to multi-task.

• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global environment.

• Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization.

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.

Benefits

• An attractive pipeline and innovative products

• Individual development opportunities and a strong focus on lifelong learning

• A high level of trust, appreciation, and space for contribution within a focused and passionate team

• A diverse, inclusive, and unbiased working environment committed to the Diversity Charter, which not only accepts but actively promotes differences, and welcomes and considers applications from all qualified candidates, regardless of their characteristics

• A sustainable company that aims to be carbon negative across its entire value chain by 2030

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.