CMC Compliance Strategy Manager - Integrations

Grünenthal Group WorkFromHome

Stellenbeschreibung:

CMC Compliance Strategy Manager - Integrations

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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