Senior Specialist, Clinical Quality Assurance - Remote

Job Description

Our Research & Development Division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research & Development Division QA Clinical Quality (CQ) provide independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials. 

Primary Responsibilities:

• Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work 

• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills 

• Influences, partners and collaborates with other colleagues within and outside their team 

• Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.

• Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits

• Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities.

• In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.

• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.

• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.

• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.

• Promotes standardization of auditing approach within QA.

• Routinely suggests new audit techniques/aids in areas of technical expertise.

• Ensures the work climate/culture within QA, exemplifies our Company's Leadership behaviors

Responsibilities relative to the Auditor Resourcer include:

• Support, advance, and drive the Clinical Quality capacity planning and assignment of GCP audits

• Lead our Research & Development Division QA Clinical Quality audit planning processes

• Implement annual audit programs into the Veeva Vault QMS system

• Perform routine QC checks and follow up with Clinical Quality and other QA functional groups on key parameters in the Veeva Vault QMS system

• Resolve scheduling conflicts for quarterly audit assignments to ensure Clinical Quality reaches its annual planned audits

• Collaborate across our Research & Development Division QA to continuously improve business processes as it relates to the new systems and tools

• Collaborate with our Research & Development Division IT organization on exploration of technologies to solve our Research & Development Division QA business needs

• Collaborate with our Research & Development Division Analytics & QA Analytics and Tech/System teams as needed on the continued evolution of data analytics and use of metrics

• Understand applicable regulations, technology, and processes to work effectively with our Research & Development Division QA functional areas and subject matter experts 

• Support the project lead/pro