Join a global pharmaceutical innovator with over a century of impact and a strong European presence. This organization is advancing the frontiers of oncology and specialty care, with a focus on biologics and cutting-edge therapies like ADCs.
We are looking for an experienced Quality Assurance Manager to take ownership of one or more key QMS processes. Whether your expertise lies in Deviation/CAPA, Change Control & Risk Management, or Complaint & Recall Handling, this role offers the opportunity to lead process improvements, ensure compliance, and collaborate across teams in a regulated environment.
Key Responsibilities
* Lead selected QMS processes based on your expertise (e.g., Deviation/CAPA, Change Control, or Complaint Handling).
* Act as regional process owner and liaison to global quality teams.
* Ensure compliance with GMP/GDP regulations and internal standards.
* Collaborate cross-functionally to optimize and align processes.
* Monitor performance metrics and drive continuous improvement.
* Maintain process documentation and deliver targeted training.
* Support audits and inspections as Subject Matter Expert.
* Stay current with regulatory developments and best practices.
Qualifications & Experience
* Degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field.
* Minimum 5 years of experience in a GMP/GDP-regulated environment.
* Proven expertise in at least one of the following areas:
* Deviation/CAPA/OOx Management
* Change Control & Risk Management
* Complaint Handling & Product Recall
* Strong skills in process design, mapping, and optimization.
* Experience with electronic QMS platforms (e.g., TrackWise, Veeva, or similar) is highly desirable.
* Excellent communication and stakeholder management skills.
* Strong analytical thinking and attention to detail.
* Solid organizational and project leadership capabilities.
* Fluency in English; additional language skills (e.g., German) are a plus.
What We Offer
* Modern and global organizational structures.
* Attractive salary with performance-based bonuses.
* New production site with an exciting project pipeline.
* A culture of mutual respect and continuous learning, characterized by diversity and inclusion.
* Opportunity for personal development and to contribute to the future of the organization.
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