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.
Responsibilities
- 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.
Education
- Bachelor’s degree in a scientific or related field is required.
Experience
- 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.
Additional Information
- 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.
