Sr. Quality Specialist

We are seeking a Senior Specialist, Quality, to lead preparation, execution and maintenance of Animal Batch Safety Test Exemption submissions and the internal controls that support them for USDA-licensed veterinary biologics. This role will take ownership of end-to-end execution of the Work Instruction for Requesting Laboratory and Target Animal Batch Safety Exemption (per VSM 800.116 and related guidance), coordinating cross-functional subject matter experts (Quality, Operations, Planning, Regulatory, Global Pharmacovigilance), compiling required evidence, preparing exemption reports and OP/SO revisions, and maintaining post-approval obligations and notifications.

This is a US remote role - Travel will be required 20% of the time to Merck sites.

Key responsibilities:

• Execute the full exemption submission process in accordance with the Work Instruction for Requesting Laboratory and Target Animal Batch Safety Exemption.
• Evaluate product eligibility against Key Inclusion Criteria (manufacturing history, laboratory and target-animal safety results, purity testing, serial history, pharmacovigilance record).
• Assemble and verify required pre-report elements (Outline of Production, inactivation studies, Individual Study Summary, production records).
• Compile and summarize Laboratory Animal Batch Safety Test (LABST) and Target Animal Batch Safety Test (TABST) descriptions and results, including APHIS Form 2008 data and bench records.
• Prepare purity testing summaries (sterility, mycoplasma and other OP-specified purity tests) for selected serials.
• Propose and justify maximum antigen content specification and product minimum/maximum potency limits for Sections IV.I and V.C of the OP/SO.
• Coordinate Global Pharmacovigilance to produce Product Safety Assessments and verify safety profiles.
• Compile documentation for manufacturing history, technology transfers, CVB-IC inspection reports, and serial release testing.
• Draft high-quality exemption reports and supporting appendices to submit to CVB in the required format (including APHIS forms, Appendix tables, ISS, and OP/SO revisions). Ensure clarity, traceability and regulatory compliance.
• Coordinate required revisions to Outline of Production (OP) and Special Outlines (SO) upon anticipated approval and ensure methods (e.g., inactivation check tests, adjuvant sterility, sterility testing method references) are adequately documented.
• Ensure internal records are complete and available for CVB review (bench records, daily observations, raw PV data, change synopses).
• Implement and maintain post-approval obligations:
• Establish and manage annual pharmacovigilance monitoring and reporting program; use Reliance Obligations module and assign responsible personnel.
• Prepare and submit annual PV updates to CVB and escalate to Regional Leadership when issues arise.
• Monitor antigen content specification and initiate re-evaluation if adverse events are detected.
• Establish and update internal notification and escalation procedures relating to safety test-exempted products (including updates to CVB notification process, OP Section V.B review steps, and actions if exemption is suspended).
• Manage cross-functional meetings, timelines and deliverables; escalate risks and propose mitigation strategies to Quality/Regulatory leadership.
• Train and mentor Quality staff and cross-functional SMEs on exemption requirements and internal processes.

Skills, Education and Experience Required:-

• Bachelor’s degree in biological sciences, microbiology, veterinary medicine, pharmacy, or related field. Advanced degree (MS, DVM, PhD) preferred.
• Minimum 5–8 years’ experience in quality, regulatory, or manufacturing support for veterinary biologics or human biologics/vaccines, including experience with batch release testing, stability, inactivation studies, or pharmacovigilance.
• Demonstrated experience preparing regulatory submissions, technical reports, or protocol/study summaries for biologics; experience with USDA/APHIS regulatory environment strongly preferred.
• Strong working knowledge of applicable regulations and guidance: VSMs (800.116, 800.117, 800.125, 800.206, 800.53, etc.), 9 CFR (particularly 9 CFR 113 and 116), VICH GL50/GL59, and APHIS forms and processes.
• Excellent technical writing skills and attention to detail; able to compile clear, well-structured exemption reports and OP/SO revisions.
• Strong project management and stakeholder coordination skills; ability to lead cross-functional teams and meet regulatory timelines.
• Proficiency with document management systems and regulatory tracking tools (experience with Reliance or similar preferred).
• Ability to review and interpret laboratory data (APIs, potency assays, sterility/mycoplasma results) and to liaise with Operations and Planning for production data.
• Strong analytical thinking and problem-solving; comfortable working with complex technical datasets.
• Meticulous attention to detail and commitment to data integrity and regulatory compliance.
• Effective communicator—able to translate technical findings into clear regulatory rationale.
• Collaborative mindset; able to build credibility with Quality, Regulatory, Operations, Planning, and PV partners.
• Proactive, organized, and deadline oriented.