cGMP Compliance and Investigations Lead

• 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 identified 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 concise 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; translate identified 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.

• Bachelor's degree in a scientific, engineering, quality, or related discipline is required; an advanced degree is preferred.
• 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; knowledge of ATMP and EU GMP Annex 1 requirements is preferred.
• 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 both SMEs and leadership.
• Proficiency with Microsoft Office applications; experience with electronic quality management systems, LIMS, MES/PAS-X, or SAP is preferred.
• Ability to work effectively in a collaborative environment, exercise sound judgment, and challenge assumptions constructively using a science- and risk-based approach.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

"If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

Required Skills: