Associate Director, Compliance Operations —Investigation Writer

MSD • Upper Gwynedd Township, PA

1d • Hybrid

About The Position

We are seeking an experienced, detail-oriented Associate Director to join the Biologics Pilot Plant (BPP) Operations team within Vaccines and Advanced Biotechnologies Process Research and Development (VAXPR&D). In this role you will lead, author, document, and drive formal investigations of process deviations, non-conformances, and incidents to determine root causes and ensure compliance with regulatory requirements and internal standards. You will partner closely with process development, manufacturing, and quality colleagues to implement corrective and preventative actions, support investigation governance, and improve operational robustness across upstream and downstream pilot operations. The position will be temporarily based in West Point, PA for approximately 18 months (up to 24 months) to support business needs. After this period, the role is intended to relocate to Rahway, NJ. Applicants should be comfortable with this planned geographic transition. In Rahway, the position will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

Requirements

• GMP manufacturing of biologics, or vaccines, and/or process development activities.
• Demonstrated experience writing and closing deviations, investigations, or CAPAs in a cGMP-regulated environment (biologics, pharmaceuticals, vaccines, or medical devices).
• Strong technical writing and editing skills with the ability to convert complex technical information into clear, succinct, and defensible reports.
• Solid knowledge of cGMP, Quality Systems, and regulatory expectations (FDA, EMA, ICH) for deviation handling and CAPA.
• Proficiency with Quality Management Systems (electronic QMS preferred), deviation tracking tools, and common office software.
• Strong investigative skills, including interviewing techniques, evidence collection, and data-driven root cause analysis.
• Excellent interpersonal skills and ability to work cross-functionally; comfortable asking probing questions of manufacturing and lab personnel.
• High attention to detail, organizational skills, and ability to manage multiple investigations concurrently while meeting deadlines.
• Sound judgment and the ability to escalate appropriately when product quality or patient safety concerns arise.

Nice To Haves

• Prior experience as a Deviation Writer, QA Investigator, Quality Control Technical Writer, or CAPA Lead.
• Formal training or certification in root cause analysis, CAPA, or quality tools (e.g., Six Sigma, RCA certification).
• Experience supporting regulatory inspections and preparing responses related to investigations and CAPA.
• Experience with trend analysis and metrics for deviation/CAPA effectiveness and continuous improvement initiatives.
• Demonstrated ability to influence in a matrixed organization and lead problem resolution teams.
• Experience drafting technical content for regulatory submissions or inspection packages.
• Demonstrates Ownership & Accountability: takes responsibility for timely, high-quality investigation outputs and follow-through on CAPA effectiveness.
• Execution Excellence: delivers accurate, audit-ready documentation with consistent attention to procedural and regulatory requirements.
• Decision Making: analyzes technical data and makes defensible recommendations about product disposition and corrective actions.
• Collaboration: builds productive relationships with operational teams and quality partners to resolve issues and improve systems.

Responsibilities

• Lead end-to-end deviation and incident investigations across manufacturing operations — initiate investigations, interview personnel, review batch records/logs/outputs, gather evidence, and draft final reports.
• Prepare, edit, and finalize deviation reports, non-conformance records, QA investigation documents, and technical write-ups suitable for internal review and regulatory submission.
• Perform thorough root cause analyses using formal tools (5 Whys, Fishbone/Ishikawa, Fault Tree) and document rationale and evidence supporting conclusions.
• Develop, document, and track Corrective and Preventive Actions (CAPAs); ensure effectiveness checks are planned, executed, and documented.
• Ensure investigations meet internal timelines and regulatory expectations (e.g., timely initiation, risk assessment, and escalation; adherence to standard SOP timeframes).
• Assess the need for product disposition recommendations (e.g., quarantine release, rework, scrap) and prepare clear justification for Quality Control decisions.
• Collaborate closely with cross-functional teams including Manufacturing, Process Development, Quality, Analytical, and Safety to obtain technical input and implement remedial actions.
• Maintain and update entries in the Quality Management System (QMS) and deviation tracking tools; ensure investigation documentation is complete, traceable, and audit-ready.
• Provide independent technical review and editorial oversight of investigation documentation prepared by site staff to ensure consistency, clarity, technical accuracy, and regulatory defensibility.
• Participate in or lead deviation trend analysis and periodic management reviews; identify systemic issues and recommend process or systems improvements.
• Train and coach site personnel on effective investigation and deviation-reporting practices, including interview techniques and evidence collection.
• Support regulatory inspections and internal audits as a subject-matter contributor for investigations and corrective action topics.
• May oversee site training function, as required, upon transfer to Rahway, NJ.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager