Global QA & Regulatory Project Lead

Grünenthal GmbH; Santiago; On-site; CLP 15,000,000 - 27,000,000; Full time

Job summary

Grünenthal GmbH in Santiago seeks an experienced regulatory project leader to drive international compliance initiatives within Global Operations & Production. You will collaborate across local and global functions to meet GMP, GLP and EMA/FDA standards.

The role requires a Pharmacy or Engineering degree with 10+ years in pharma production and a proven leadership track in audits and continuous improvement. English at C1 level is essential; onsite work in Chile with a dynamic, collaborative team.

Qualifications

• Degree in Pharmacy, Industrial Engineering, or related field.

Responsibilities

• Lead strategic international regulatory compliance projects from planning through closure.
• Coordinate project execution with local and global functions using defined methodologies.
• Prepare Santiago Site to meet international regulatory requirements and Grünenthal standards.
• Assess compliance gaps and define action plans with monitoring of progress.
• Coordinate teams and stakeholders, aligning responsibilities and timelines.

Skills

Regulatory compliance

Project management

GMP / GLP knowledge

English proficiency

Cross-functional collaboration

Education

Degree in Pharmacy or Industrial Engineering

10+ years pharma manufacturing experience

Tools

GAMP 5

EMA/FDA standards

Job description

Grünenthal GmbH in Santiago seeks an experienced regulatory project leader to drive international compliance initiatives within Global Operations & Production. You will collaborate across local and global functions to meet GMP, GLP and EMA/FDA standards.

The role requires a Pharmacy or Engineering degree with 10+ years in pharma production and a proven leadership track in audits and continuous improvement. English at C1 level is essential; onsite work in Chile with a dynamic, collaborative team.