Senior Specialist, Clinical Quality Assurance - Remote

Quality Assurance Clinical Quality Auditor

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 include :

• Leading their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work
• Contributing to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills
• Influencing, partnering and collaborating with other colleagues within and outside their team
• Preparing, conducting QA audits, generating audit reports, communicating results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacting with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Being 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, supporting the QAL in the identification of audit substrate for scheduling, as appropriate.
• Ensuring appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects / products, to the QAL and TA Head.
• Interfacing and providing day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
• Assessing 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.
• Promoting standardization of auditing approach within QA.
• Routinely suggesting new audit techniques / aids in areas of technical expertise.
• Ensuring the work climate / culture within QA, exemplifies our company's leadership behaviors

Responsibilities relative to the Auditor Resourcer include :

Education :

Requirements :

Enterprise Leadership Skills :

Required Skills :

Preferred Skills :

Salary range for this role is $104,200.00 - $163,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical