Global QA & Regulatory Projects Lead

Grünenthal GmbH; Santiago; On-site; CLP 9,000,000 - 14,000,000; Full time

Job summary

Grünenthal GmbH in Santiago is seeking a seasoned Regulatory Compliance Leader to drive international regulatory projects and ensure GMP/GxP adherence. You will coordinate cross-functional teams, prepare the site for global inspections, and implement improvements aligned with company standards and ALCOA++ principles.

The role requires 10+ years in pharma regulatory roles, advanced English, and a proven track record in audits across Europe, the USA, or other regulated markets.

Qualifications

• 10+ years in pharmaceutical manufacturing/regulatory roles.
• Proven leadership in cross-functional teams and international audits.
• Strong knowledge of GMP/GLP, EMA/FDA requirements, and regulatory standards.

Responsibilities

• Lead strategic international regulatory compliance projects from planning to closure.
• Coordinate execution with local and global functions using Grünenthal methodologies.
• Prepare the Santiago Site to meet international regulatory requirements and company standards.
• Identify gaps, define action plans, monitor progress, and ensure sustainable implementations.
• Lead teams and stakeholders, align priorities, and manage timelines and resources.
• Oversee EHS matters and ensure documentation adheres to ALCOA++ and GMP/GxP rules.

Skills

Regulatory Compliance

Project Management

GMP/GxP

Audits

Leadership

Education

Pharmacy

Industrial Engineering

Job description

Grünenthal GmbH in Santiago is seeking a seasoned Regulatory Compliance Leader to drive international regulatory projects and ensure GMP/GxP adherence. You will coordinate cross-functional teams, prepare the site for global inspections, and implement improvements aligned with company standards and ALCOA++ principles.

The role requires 10+ years in pharma regulatory roles, advanced English, and a proven track record in audits across Europe, the USA, or other regulated markets.