[Remote] Senior Specialist, Quality Assurance, Clinical Quality
Note: The job is a remote job and is open to candidates in USA. Merck is a global healthcare company dedicated to improving and saving lives. They are seeking a Senior Specialist in Quality Assurance who will lead QA audits, ensure compliance with regulatory requirements, and support the quality oversight of clinical studies to uphold product integrity and participant safety.
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
Skills
- BS/BA degree or equivalent and/or 3-5 years experience in a relevant field
- Proficiency in the primary activities and essential skills required for this role
- 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
Benefits
- Annual bonus and long-term incentive, if applicable
- 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
Company Overview