Senior QA Project Manager

Grünenthal Group

. Lead strategic international regulatory compliance projects from planning through implementation and closure .

Posted 11/10/2026full-timeSantiago • ChileSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading international regulatory compliance projects, ensuring adherence to GMP, GLP, and GxP standards while managing project scope, resources, and risks. Proven ability to coordinate teams and stakeholders effectively, driving sustainable implementation and compliance with global regulatory requirements.

Highest-signal resume keywords

Regulatory Compliance ManagementGMP and GLP ExpertiseProject Management MethodologiesLeadership in Quality AssuranceAdvanced English Proficiency (C1)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceProject ManagementGMP RegulationsGLP RegulationsContinuous ImprovementGAMP 5 KnowledgeQuality AssuranceQuality ControlInternational AuditsPharmaceutical Manufacturing

Soft Skills

Team CoordinationStakeholder ManagementProblem SolvingCoachingEmployee Engagement

Tools & Technologies

Project Management ToolsEHS Management SystemsQuality System Reporting

Industry Keywords

Pharmaceutical IndustryEMA RegulationsFDA RegulationsISPE GuidelinesALCOA++ Principles

About the role

Key responsibilities & impact

Lead strategic international regulatory compliance projects from planning through implementation and closure
Manage project scope, objectives, milestones, resources, and budget
Coordinate project execution with local and global functions using Grünenthal’s project management methodologies and tools
Prepare the Santiago Site to meet international regulatory requirements and global standards
Assess compliance gaps, define action plans, monitor progress, and ensure sustainable implementation
Coordinate teams and stakeholders, aligning responsibilities, deliverables, priorities, and timelines
Resolve and escalate critical issues affecting project execution
Manage project risks, dependencies, deviations, and changes, defining mitigation measures
Coordinate and monitor contingency plans for regulatory compliance and project risks
Lead employees on Environment, Health and Safety matters and support EHS management systems
Comply with ALCOA++ principles, GMP, and GxP requirements; report deviations through the Quality System
Manage team performance, objectives, development plans, feedback, coaching, and employee engagement

Requirements

What you’ll need

Degree in Pharmacy, Industrial Engineering, or a related field
≥10 years of experience in pharmaceutical manufacturing sites
≥5 years of experience in a leadership role within Quality Assurance, Production, or Quality Control
Experience in pharmaceutical companies with products exported to Europe, the USA, or other highly regulated markets
Expertise in GMP and GLP regulations and international standards, including EMA or FDA requirements
Proven experience supporting and defending international audits and inspections
Experience leading GMP and/or Continuous Improvement projects
Knowledge of GAMP 5, EMA, FDA, and ISPE regulations and guidelines
Advanced English proficiency at C1 level

Benefits

Comp & perks

Permanent employment
Full-time employment
On-site work
Safe and motivating work environment
Performance management, feedback, coaching, and one-to-one meetings
Support for Personal Development Plans (PDP)
Opportunities to contribute to EHS initiatives and continuous improvement