(Senior) Clinical Quality Associate Director 12 month secondmentfixed term contract

The Clinical Quality Associate Director (CQAD) is primarily responsible for maintaining developing andcommunicating high-quality standards in the delivery of clinical studies. This includes playing a central role incoordinating and meeting the training needs of the local Site Management & Monitoring (SMM) team throughclose collaboration with local SMM leadership and reporting to Director Country Head.

This role acts as the primary advisor on compliance and process matters within the local SMM team proactivelyidentifying and pursuing opportunities to drive quality and process improvements at local regional and global
levels.
A key aspect of the role is the development implementation and continuous oversight of local proceduraldocuments as well as ensuring up-to-date knowledge of local regulations and industry practices pertaining toclinical trials. The CQAD supports audit and inspection activities serving as the primary point of contact forauditors and inspectors in their local SMM organization.
Working collaboratively with the local SMM leadership team the CQAD assists in planning and executing allquality control activities and applies robust risk management principles to assess compliance issues and
implement effective solutions. The CQAD stays informed about business compliance matters working closelywith the Regional Director Clinical Quality (RDCQ) and actively engaging with key regional and global networks.
This Job description applies to both senior and non-senior role levels with additional responsibilities andexpectations applicable for the senior role defined in document Site Management and Monitoring (SM&M)Biopharmaceuticals Senior Role Definition

Responsibilities

Accountabilities for this role include:

• Advise Local Study Teams on AstraZeneca procedural frameworks international guidelines such as ICHGCP industry standards and relevant local regulations.

• Provide accurate and timely updates on local clinical trial regulations ensuring teams are aware of anychanges affecting compliance.

• Support local management in planning and executing Quality Control (QC) activities as outlined in thelocal QC plan.

• Offer expert guidance and support to local management in addressing and resolving quality-specificconcerns at the local level.

• Assist local teams with audit and regulatory inspection preparation execution and response activitiesensuring readiness and effective follow-up.

• Advise Local Study Teams on resolving audit and inspection findings and assists with implementingcorrective actions.

• Facilitate knowledge sharing by communicating audit and inspection learnings to local staff and theregional CQAD network as well as cascading global/regional insights on the local level.

• Oversee country-level risk management identifying and supporting mitigation actions to addresscompliance risks.

• Serve as a key contact in the evaluation and management of fraud or misconduct cases liaising withQuality Assurance the Regional Director Clinical Quality (RDCQ) and local management as needed.

• Identify ongoing and ad hoc training needs for local staff and coordinate or deliver training incollaboration with local SMM leadership.

• Support the local implementation of global procedures and systems by providing feedback onprocedural documents delivering local training as required and collecting and escalating user questionsand issues liaising with local subject matter expert if applicable.

• Lead or contribute to the implementation of systems and tools for delivering clinical operational tasksSOPs and ICH-GCP requirements at the local level.

• Oversee development maintenance training and archiving of Local Procedural Documents ensuringalignment with global processes ICH-GCP and local regulations.

• Act as the primary local interface for Quality Assurance.

• Actively participate in the Clinical Quality Associate Directors Network at the regional level contributingto shared goals and best practices.

• Represent the organization in local regulatory or operational expert groups as required.

• Provide expert opinions on local regulations related to clinical trials when requested by otherdepartments.

• Deliver training to investigational site staff on ICH-GCP and local regulations when additional support isneeded.

Requirements

Education and experience:

• Bachelors degree in related discipline preferably in life science or equivalent qualification aligned to theknowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactionswith internal and or external stakeholders.

• Previous experience in the pharmaceutical industry preferably in Clinical Operations/Quality Assurance.

• Relevant knowledge and ability to fulfil key responsibilities including but not limited to:

• Drug development process and related GxP processes International guidelines ICH-GCP relevant countryregulations medical knowledge and ability to learn relevant AZ Therapeutic Areas Clinical Study Managementincluding monitoring study drug handling and data management.

• Personal Effectiveness & Drives Accountability in Others

• Learning Agility

• Financial Technology & Process Competency

• Active Listening Fluency in written & spoken business-level English

• Act with Integrity & high ethical standards

• Effectively lead a team across in-person and virtual settings to deliver shared goals demonstratescultural awareness

• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time

• Ability to travel nationally/internationally as required

• Valid driving license if country employment requirement

• Communication & Teamwork Influencing Training & workshop facilitation

• Effective risk-based thinking Problem Solving Critical Thinking Decision Making Strategic Thinking

• Effective Issue Management

• Clinical Study Operations (GCP) & Quality Management - Audit & Inspection Readiness Process

• Management & Improvement

• Leadership Enable Change Feedforward & Coaching.

Date Posted

Closing Date

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.