Senior Specialist, Clinical Quality Assurance at Merck in Boise, Idaho, United States Job Description Job Description In partnership with the Quality Assurance Lead, the Quality Assurance Sr. Specialist will support the implementation and management of the Quality assurance strategy across multiple studies and countries. The Quality Assurance Sr. Specialist (QAS) will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of patients. The QAS will be responsible for the execution of the global Quality Assurance audit activities on assigned studies, products, and Country Offices. This role is responsible for Good Clinical Practice oversight and for assuring the compliance of studies with our Standard Operating Procedures, Policies and all applicable worldwide regulations and guidelines. Primary activities include but are not limited to: Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external stakeholders and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable. Represents QA and provides guidance from a QA perspective for studies for the assigned Therapeutic Area and applicable countries. Supports project team when required, providing Good Clinical Practice compliance advice and guidance to stakeholders to achieve continuous quality improvement and effective quality controls. Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, from a quality assurance perspective. Contributes to the QA strategy and supports QA goals for the aligned studies in the given Region. Proactively identifies, analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies. In alignment with risk assessments, supports the identification and selection of investigator sites, process, studies, and programs for audit as appropriate. Ensures appropriate and timely escalation of quality issues. Provides inspection management support as appropriate. Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents. What skills you will need: In order to excel in this role, you will more than likely have: BS/BA degree in a relevant area, Science or Engineering discipline ideal. Minimum of five (5) years' experience in the pharmaceutical/biotechnology industry. Demonstrated analytical, problem-solving and communication (oral/written) skills are required. Ability to travel, both domestically and internationally. Comprehension of drug development life cycle is required. Previous experience in quality assurance and GCP auditing is preferred. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. 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Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. 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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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Please note, this Hybrid work model guidance also does not apply to roles that have been designated as 'remote'. Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will tak To view full details and how to apply, please login or create a Job Seeker account