Senior Specialist, Clinical Quality Assurance - Remote

Job Posting

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.

The 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.
• Interfaces and provides 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.
• 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 :

Education :

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.

Requirements :

Enterprise Leadership Skills :

Required Skills :

Preferred Skills :

The 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, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

Employee Status : Regular

Relocation : No

VISA Sponsorship : No

Travel Requirements : 50%

Flexible Work Arrangements : Remote