cGMP Compliance and Investigations Lead

Johnson & Johnson•Spring House, PA

21h

About The Position

The cGMP Compliance and Investigations Lead provides technical and compliance leadership for deviation, non-conformance, assay-failure, and atypical-event investigations supporting cell therapy development and clinical manufacturing. The role leads root cause analysis and risk assessment, develops effective corrective and preventive actions (CAPAs), monitors quality-system performance and trends, supports regulatory gap assessments and change controls, and maintains inspection-ready documentation. Working cross-functionally with Manufacturing, Quality Assurance, Quality Control, and technical teams, this position communicates risk and status to leadership and advances phase-appropriate cGMP compliance and continuous improvement. The role also serves as an investigation and compliance subject-matter expert during audits and health-authority inspections, and coaches colleagues on investigation practices and cGMP expectations.

Requirements

Bachelor's degree in a scientific, engineering, quality, or related discipline.
Multiple years of progressive experience in the pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy industry, including direct responsibility for cGMP investigations, deviations, CAPAs, or quality-system compliance.
Demonstrated ability to lead complex investigations, apply root cause analysis and risk-management tools, identify defensible root causes, and translate findings into effective and sustainable CAPAs.
Working knowledge of cGMP regulations, FDA and EMA expectations, data integrity, good documentation practices, and quality systems.
Experience authoring and reviewing controlled documents, investigation reports, CAPAs, change controls, trend reports, and audit or inspection responses.
Strong analytical, facilitation, project-management, and problem-solving skills, with the ability to manage multiple priorities and drive cross-functional actions to closure.
Excellent written and verbal communication skills, including the ability to communicate technical conclusions, compliance risk, and recommended actions to SMEs and leadership.
Proficiency with Microsoft Office applications.
Ability to work effectively in a collaborative environment, exercise sound judgment, and challenge assumptions constructively using a science- and risk-based approach.

Nice To Haves

An advanced degree.
Knowledge of ATMP and EU GMP Annex 1 requirements.
Experience with electronic quality management systems, LIMS, MES/PAS-X, or SAP.

Responsibilities

Lead timely, thorough investigations of deviations, non-conformances, laboratory or assay failures, and atypical events; apply structured root cause analysis and documented risk assessment to determine product, process, and compliance impact.
Develop, coordinate, and verify effective CAPAs that address root causes, mitigate recurrence risk, and meet cGMP and audit-readiness expectations.
Maintain compliant, accurate, and complete investigation, CAPA, and change-control records; author and revise SOPs, reports, risk assessments, and other controlled technical documentation.
Track deviation and CAPA performance, identify recurring or systemic issues, and provide trend reports with actionable recommendations to functional and site leadership.
Conduct regulatory and procedural gap assessments against applicable FDA, EMA, ATMP, and EU GMP Annex 1 expectations, and translate gaps into risk-based remediation plans.
Support change-control activities by evaluating compliance impact, technical feasibility, implementation readiness, and required documentation or training.
Partner with Manufacturing, QA, QC, and technical SMEs to troubleshoot process, equipment, environmental monitoring, microbiology, sterility, and analytical-assay issues.
Serve as an investigation and compliance SME during internal audits, health-authority inspections, and regulatory-response preparation; ensure supporting materials are complete, consistent, and inspection ready.
Facilitate cross-functional review meetings, communicate status and risks to stakeholders, escalate barriers appropriately, and drive actions to closure.
Coach and train colleagues on investigation practices, root cause analysis, CAPA effectiveness, good documentation practices, and phase-appropriate cGMP expectations.
Identify and implement continuous improvements within the quality system using data, risk-based decision-making, and established change-control processes.