Senior Specialist, Quality Assurance- Remote

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.

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 Influences, partners and collaborates with other colleagues within and outside their team Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. Travel 50% - 70% 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.

Minimum Requirements: Minimum 3 years relevant industry experience for applicants with a BS/BA degree or equivalent and/or experience in a relevant field, along with proficiency in the primary activities and essential skills required for this role. Preferred Responsibilities: 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. Responsibilities relative to the Auditor Resource include: Support, advance, and drive the Clinical Quality capacity planning and assignment of GCP audits #eligibleforERP Required Skills: Audits Compliance, Clinical Quality Management, Clinical Trials, Data Integrity, Detail-Oriented, Interpersonal Relationships, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Systems 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 the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin,