Quality Investigations Coach

Job Title: Quality Investigations Coach Job Description The Quality Investigations Coach is responsible for reviewing, mentoring, and elevating the quality of deviation and investigation records within a GMP-regulated environment. This role serves as a subject matter expert in investigative writing and root cause analysis, partnering closely with Quality, Manufacturing, and other cross-functional teams to ensure investigations are thorough, compliant, and inspection-ready. Unlike a traditional investigator role, this position focuses on coaching, quality oversight, and the continuous improvement of investigation practices across the organization, helping to reduce backlog and support timely delivery of critical products to patients. Responsibilities Review deviations, CAPAs, and investigation reports to ensure clarity, completeness, and compliance with GMP, FDA, and internal quality standards. Provide detailed, constructive feedback to investigators to improve technical writing quality, investigation structure, and documentation practices. Identify trends and recurring gaps in investigations and drive continuous improvement initiatives to strengthen investigation quality and consistency. Serve as a coach and mentor to Quality Investigators and cross-functional partners, providing real-time guidance on root cause analysis, investigation storytelling, and regulatory expectations. Support the onboarding and development of new investigators by sharing best practices and modeling high-quality investigative writing and reasoning. Drive consistency and standardization in investigation approaches, documentation formats, and quality expectations across the site. Support the development, refinement, and implementation of investigation templates, SOPs, and best practices to enhance investigation excellence. Partner with Quality leadership to elevate site-wide investigation capabilities and promote a strong quality and compliance culture. Collaborate closely with Quality Assurance, Manufacturing/Operations, and Engineering to align on investigation outcomes and effective corrective and preventive actions. Facilitate cross-functional agreement on root causes, CAPAs, and follow-up activities to ensure robust and sustainable solutions. Act as a key partner during internal audits and regulatory inspections, helping to present and defend investigation quality and outcomes. Identify systemic issues revealed through deviations and investigations and recommend process improvements to prevent recurrence. Support inspection readiness activities by ensuring investigations and related documentation are complete, accurate, and audit-ready. Ensure alignment with GxP and data integrity standards in all investigation-related activities and documentation. Leverage electronic quality management systems (eQMS) to review, track, and oversee deviation and investigation records efficiently. Essential Skills Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience. 7–10+ years of experience in a GMP-regulated environment such as pharmaceutical, biotechnology, or medical device manufacturing. At least 2+ years of experience supporting operations-based deviations and quality investigations in a GMP manufacturing environment. Proven ability to independently write and close investigations tied to manufacturing processes. Strong experience in deviation investigations and CAPA management. Hands-on experience with root cause analysis methodologies, such as 5 Whys and Fishbone (Ishikawa) analysis. Deep understanding of GMP, FDA, and regulatory expectations related to deviations, investigations, and CAPAs. Strong understanding of batch record review, manufacturing workflows, and GMP documentation practices. Experience working in electronic quality systems (eQMS), including platforms such as Veeva Vault. Experience reviewing or approving investigations for quality and compliance. Excellent technical writing skills, with the ability to clearly and logically present investigation narratives and conclusions. Strong critical thinking skills, with the ability to analyze complex issues and identify true root causes. Effective stakeholder communication skills, with the ability to influence and guide cross-functional partners. Demonstrated knowledge of GMP, GxP, and data integrity principles as they relate to investigations and documentation. Additional Skills & Qualifications Prior experience in a coaching, mentoring, or quality oversight role focused on investigations or CAPAs. Experience supporting