Senior Specialist, Quality Assurance, Clinical Quality

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Job Description Our Research Laboratories 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 Laboratories 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 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 the company's Leadership behaviors Education BS/BA degree or equivalent and/or 3-5 years experience in a relevant field, along with proficiency in the primary activities and essential skills required for this role. Enterprise Leadership Skills Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed Execution Excellence - Taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive. Emotional Intelligence - Meeting the personal needs of individuals to build trust, encourage two-way communication, build allyship and strengthen relationships Networking and Partnerships - Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Coaching and Development - Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact. Talent Growth - Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application. #ERPeligible Required Skills: Analytical Thinking, Audits Compliance, Clinical Research, Clinical Trials, Detail-Oriented, Ethical Compliance, GCP Auditing, Investigative Skills, Metrics Analysis, Multiple Therapeutic Areas, Process Improvements, Stakeholder Management, Taking Ownership, Technical Documentation Management, Time Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during th

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