QA Senior Project Manager

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

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Department: Global Operations & Production

Job ID: 45542

Professional | Permanent | Full-time | On-Site

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Every day, you will enjoy a variety of challenges, such as:

• Lead strategic international regulatory compliance projects, from planning through implementation and closure, managing scope, objectives, milestones, resources, and budget.
• Coordinate project execution with the relevant local and global functions, using the project management methodologies and tools defined by Grünenthal.
• Manage the preparation of the Santiago Site to meet international regulatory requirements and Grünenthal’s global standards.
• Assess compliance gaps and define action plans, monitoring progress and ensuring the sustainable implementation of required processes and practices.
• Coordinate the teams and stakeholders involved, aligning responsibilities, deliverables, priorities, and timelines to achieve project objectives.
• Facilitate the timely resolution and escalation of critical issues that may impact project execution.
• Manage project risks, dependencies, deviations, and changes, assessing their impact and defining appropriate mitigation measures.
• Coordinate and monitor contingency plans for risks that could compromise regulatory compliance or project objectives.
• Lead and engage employees within your team and area on Environment, Health and Safety (EHS) matters. This includes actively participating in EHS initiatives, approving applicable Management System documentation, appropriately allocating resources to implement, control, and continuously improve EHS management systems, and ensuring compliance with the legal requirements applicable to your areas.
• Rigorously comply with ALCOA++ principles in all documentation processes associated with your role, as well as Good Manufacturing Practices (GMP) and GxP requirements throughout all activities performed within your area, reporting any deviations or anomalies related to applicable legal requirements or internal procedures through the Quality System.
• Manage your team holistically within a safe and motivating environment, aligned with our ambition to be a great place to work. Maintain close performance management, ensuring that employees have appropriate objectives aligned with the company’s strategy and supporting their performance and Personal Development Plans (PDP) through frequent feedback, coaching, and one-to-one meetings. Lead by example by promoting our corporate values and a culture of continuous improvement, balancing business results with the development, engagement, and overall experience of your employees

What you'll bring to the table

To excel in this role, we are looking for:

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

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Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the‑art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.