CMC Compliance Strategy Manager - Integrations

Gr?nenthal GmbH; Aachen; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Aachen seeks a CMC Compliance Strategy Manager to oversee integration projects, ensuring alignment with regulatory standards. The ideal candidate must have a scientific degree and 8–10 years in Regulatory CMC or Quality Assurance. Responsibilities include conducting due diligence assessments and developing best practices. Strong communication skills and regulatory knowledge are essential. Join our team and contribute to innovative solutions in pain management.

Qualifikationen

• 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.

Aufgaben

• Coordinate CMC efforts for integration projects, ensuring alignment with standards.
• Conduct CMC due diligence assessments and risk mitigation planning.
• Develop CMC best practices and tools to optimize integration processes.

Kenntnisse

Regulatory CMC

Quality Assurance

Technical Operations

Communication

Stakeholder Management

Strategic Thinking

Problem Solving

Attention to Detail

English Communication

Ausbildung

Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, or related scientific degree

Jobbeschreibung

CMC Compliance Strategy Manager - Integrations

Department: Global Operations & Production

Job ID: 45002

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

• 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;
• Ensures 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 workstreams within broader integration projects;
• Acts as primary business partner to senior leaders, managing complex integration workstreams and establishing consistent processes and frameworks.

What you’ll bring to the table

• 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.

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 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.