
Quality Assurance Manager
5 days ago
At Magle Chemoswed, we are dedicated to enabling life-changing therapies for patients worldwide. As a trusted CDMO, we collaborate with our partners to bring innovative biopharmaceuticals to market, leveraging cutting-edge technologies and GMP facilities in Malmö, Sweden.
We specialize in delivering comprehensive solutions across the pharmaceutical lifecycle, from early-stage drug development to commercial manufacturing. Our state-of-the-art GMP facilities bring together cutting-edge technologies and expert teams to develop, manufacture, and optimize innovative therapies that impact patients' lives worldwide.
The position of QC Manager is key to leading and inspiring our Quality Control team, ensuring analytical excellence and compliance across multiple stages of product development. This role offers an opportunity to work in a dynamic environment where collaboration and innovation drive the delivery of high-quality pharmaceuticals.
Key Responsibilities:
- Manage and develop a team of QC scientists and foster a culture that reflects our company values with a focus on quality and continuous improvement.
- Oversee analytical method development, validation, and impurity profiling to ensure regulatory compliance.
- Drive process optimization initiatives to improve efficiency, reliability, and scalability in testing.
- Coordinate cross-functional efforts with R&D and manufacturing teams to support product development milestones.
- Ensure compliance with GMP standards and lead efforts during audits and regulatory inspections.
- Support the development and validation of analytical methods, including advanced instrumentation like HPLC, UPLC, and FTIR.
Qualifications:
- Degree in a relevant scientific field (e.g., chemistry, pharmacy, or related discipline).
- Extensive experience in a GMP-regulated pharmaceutical environment, with a strong focus on analytical development.
- Proven leadership experience, with the ability to motivate and manage diverse teams.
- Expertise in analytical techniques and regulatory standards such as ICH Q3C, Q3D, and USP.
- Exceptional organizational and communication skills, with a proactive and problem-solving mindset.
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