Associate Director, Compliance Operations – Investigation Writer

MSD

Associate Director overseeing deviation investigations in Biologics Pilot Plant Operations. Collaborate with teams to ensure compliance and improve operations across manufacturing facilities.

Posted 5/3/2026full-timeWest Point • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $142,400 - $224,100 per yearWebsite

About the role

Key responsibilities & impact

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.
Travel: Up to 25% travel is required for trainings, key face-to-face meetings, and on-site investigations, primarily to West Point for a duration of 18-24 months.

Requirements

What you’ll need

Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biochemistry, Chemical Engineering) with a minimum of 7 years’ relevant experience OR Master’s degree with a minimum of 5 years’ relevant experience in pharmaceutical/biologics/vaccine manufacturing, QA/QC, or a related regulated environment.
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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

root cause analysis5 WhysFishbone/IshikawaFault TreeCorrective and Preventive Actions (CAPAs)technical writingdeviation handlingGMP manufacturingQuality Systemsregulatory compliance

Soft Skills

interpersonal skillsorganizational skillsattention to detailinvestigative skillscommunication skillscross-functional collaborationjudgmentcoachingtrainingproblem-solving