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CMC Compliance Strategy Manager - Integrations

Job in Menlo Park, San Mateo County, California, 94029, USA
Listing for: Gr?nenthal GmbH
Full Time position
Listed on 2026-03-15
Job specializations:
  • Healthcare
    Healthcare Management
  • Management
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

Overview

Country:
Portugal

City:
Lisbon

Department:
Global Operations & Production

Job

Job Grade: PT13F

Internal Posting Date: 05/02/2026

Professional | Permanent | Full-time | Hybrid

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

Responsibilities
  • Coordinate CMC efforts for integration projects, ensuring that the CMC roles participating in integration projects are aligned with the integrations standards and priorities;
  • Conduct CMC due diligence assessments and risk mitigation planning;
  • Identify and resolve gaps in the CMC documentation to ensure regulatory compliance during transitions;
  • Ensure that the quality and manufacturing aspects of drug products and drug substances are integrated efficiently and in compliance with the global CMC regulatory standards;
  • Develop CMC best practices and tools to optimize integration processes;
  • Monitor timelines and deliverables to ensure successful execution of CMC work streams within broader integration projects;
  • Act as primary business partner to senior leaders, managing complex integration work streams and establishing consistent processes and frameworks.
Qualifications
  • Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, or related scientific degree;
  • 8–10 years experience in Regulatory CMC, Quality Assurance or Technical Operations in the pharmaceutical industry;
  • Experience in leading CMC strategy for integration efforts in M&A and tech transfers;
  • Strong knowledge of ICH guidelines, GMP regulations and regulatory frameworks worldwide (e.g. EU, US);
  • Experience with global regulatory CMC submissions and GMP compliance across product lifecycle;
  • Excellent communication and stakeholder management skills;
  • Ability to work independently and within cross-functional teams and lead through influence;
  • Strategic thinking, high attention to detail and problem-solving skills;
  • Excellent written and verbal communication skills in English.
About Grünenthal

Ana Lúcia Vasconcelos, the Hiring Manager

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 focusing 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.

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