Senior Quality Specialist - Legal: Risk & Compliance
On-siteSantiago, Santiago Metropolitan, Chile
Job Summary
Manage the full Quality Event lifecycle from initiation through closure, ensuring thorough documentation in the Quality Management System and assessing criticality based on impact to participant safety, data integrity, and regulatory compliance. Lead investigations to determine root cause using structured methodologies, coordinate cross-functional input from Subject Matter Experts, and develop corrective and preventive actions that are specific, measurable, and achievable. Track CAPAs through implementation to closure, manage timeline adherence, and execute effectiveness checks to verify that issues have not recurred and that controls are strengthened. Support quality audits by preparing documentation and participating in inspection activities, while serving as a Subject Matter Expert for reviewing and approving Standard Operating Procedures and Work Instructions. Develop and present quality KPI dashboards, trend reports, and management summaries to internal leadership and customers, translating data into actionable intelligence. Provide structured mentorship to junior team members by reviewing investigations and CAPA plans prior to submission, ensuring all documentation meets GxP standards. This six-month fixed-term role requires a Bachelor's degree and five years of experience in a GxP-regulated environment.
Required Qualifications
- Bachelor's degree
- Degree in Life Sciences, Pharmacy, Engineering, or a related field
- Minimum five (5) years of experience in a GxP-regulated environment
- At least two (2) years in a quality specialist or equivalent role
- Demonstrated experience managing Quality Events and CAPAs in a Quality Management System
- Proficiency in root cause analysis methodologies (e.g., 5-whys, fishbone diagrams)
- Strong understanding of CAPA lifecycle management and effectiveness verification principles
- Excellent written and verbal communication skills
- Ability to articulate complex issues clearly
- Strong analytical thinking and attention to detail in investigation documentation
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment
- Self-directed with strong organizational and time management skills
- Demonstrated ability to mentor, guide, and provide quality oversight to junior team members in a GxP-regulated setting
- Proven ability to independently manage customer-facing quality communications
- Experience developing and presenting quality metrics and trend analyses to management and/or customers
Desired Qualifications
- Experience in clinical trial operations or life sciences industry
- Familiarity with ICH guidelines (E6, Q9, Q10) and risk-based quality management principles
- Experience with trend analysis and quality metrics reporting
- Familiarity with software development lifecycle (SDLC) processes and methodologies
- Quality certifications (ASQ CQA, CQE, or similar)
- Experience authoring, reviewing, or owning GxP SOPs and Work Instructions as a Subject Matter Expert
- Exposure to clinical trial technology platforms (e.g., RTSM, eCOA, EDC)
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