Senior Quality Lead - Risk & Compliance (CAPA & Audits)

Signant Health; Santiago; Presencial; CLP 59.361.000 - 86.758.000; Jornada completa

Descripción de la vacante

Signant Health is seeking a Senior Quality Specialist to lead Quality Events and CAPAs end-to-end within a six-month fixed-term role in Chile. The position emphasizes risk-based investigation, cross-functional collaboration, and ensuring robust corrective actions with sustainability.

You will act as a quality resource for teams, support audits and customer communications, and mentor junior members while upholding GxP standards and regulatory expectations.

Formación

• Bachelor’s degree required; degree in Life Sciences, Pharmacy, Engineering, or related field preferred.
• Minimum five years of experience in a GxP-regulated environment with at least two years in a quality specialist or equivalent role.
• Experience managing Quality Events and CAPAs in a Quality Management System (QMS).
• Proficiency in root cause analysis methodologies (e.g., 5-Whys, fishbone diagrams).
• Strong written and verbal communication skills with ability to mentor junior team members.

Responsabilidades

• Lead Quality Event lifecycle from initiation to closure with thorough QMS documentation.
• Conduct root cause analysis, trend management, and CAPA planning with cross-functional input.
• Collaborate with Operations, Project Management, Technical Delivery, and Customer Delivery to drive resolution.
• Develop quality metrics, dashboards, and reports for senior leadership and customers.
• Provide guidance on investigations, SOPs/WINs, and training for staff in a GxP setting.

Educación

Bachelor's degree

Descripción del empleo

Signant Health is seeking a Senior Quality Specialist to lead Quality Events and CAPAs end-to-end within a six-month fixed-term role in Chile. The position emphasizes risk-based investigation, cross-functional collaboration, and ensuring robust corrective actions with sustainability.

You will act as a quality resource for teams, support audits and customer communications, and mentor junior members while upholding GxP standards and regulatory expectations.