Quality Specialist - II

We are seeking a detail‑oriented Quality Assurance professional to join the Merck Animal Health (MAH) Global Research and Development team. This critical role serves as a member of the Quality Assurance Unit (QAU), ensuring that all animal health studies and data collection processes remain in strict compliance with VICH GCP and FDA/EPA GLP regulations. You will act as a key safeguard for our R&D pipeline, overseeing the systematic processes that lead to high‑quality regulatory submissions for CVM, EPA, and international agencies.

If you are a proactive auditor who enjoys collaborating with study monitors and directors to maintain the highest industry standards, this is an impactful opportunity to support global animal health innovation.

• Plan and conduct comprehensive study inspections, facility audits, and data/report reviews to ensure compliance with SOPs and government regulations.
• Review animal health bioanalytical studies conducted in‑house, specifically auditing GLP data within Analyst and Watson LIMS systems.
• Perform external facility inspections and audits of Contract Research Organizations (CROs) used for GCP and GLP study support.
• Issue and track detailed audit reports to Study Directors and Management, ensuring appropriate corrective actions are documented and resolved.
• Review and provide technical feedback on study protocols and amendments for internal consistency and regulatory alignment.
• Assist Global R&D QA leadership during official government (FDA, EPA) or corporate inspections of MAH facilities.
• Develop, revise, and maintain SOPs governing the R&D Quality Assurance department and other R&D functions.
• Provide GCP and GLP regulatory compliance training to internal personnel and external business partners.
• Monitor and report on GCP workload status and study performance metrics to senior management.

• Bachelor’s degree in a scientific or related field is required.

• Regulatory Expertise:
  Minimum of 5 years of related experience in a regulated environment, with at least 2 years specifically in an auditing role.
• Compliance Knowledge:
  Deep understanding of VICH GCP GL9, FDA 21 CFR Part 58 (GLP), and EPA 40 CFR Part 160 guidelines.
• Technical
  
  Skills:
  
  Hands‑on experience with Bioanalytical Method Validation (LC/MS‑MS preferred) and proficiency in LIMS systems (Watson/Analyst).
• Communication:
  Proven ability to facilitate meetings, lead training sessions, and produce high‑quality technical writing and audit reports.

• Travel:
  This position requires the ability to travel up to 25% annually for facility and vendor audits.
• Key Impact:
  This role is essential for the completion of final study reports required for global regulatory submissions.
• Environment:
  Candidates must be able to perform effectively in a multi‑tasking, fast‑paced environment and lead cross‑functional teams to meet strict regulatory timelines.