Senior Technical Operations Manager
Company Overview:
- A global leader of in vitro diagnostics with over five decades of experience advancing healthcare through scientific and technological innovation is looking for a new Senior Technical Operations Manager. This company continues to deliver high quality, reliable solutions that enhance clinical decision-making and improve patient outcomes worldwide.
Responsibilities:
- Ensure regulatory compliance by supporting audits, maintaining documentation, and aligning processes with quality standards.
- Provide technical leadership in the design, development, and implementation of products, processes, and specifications, collaborating with cross-functional teams.
- Monitor and improve quality performance by establishing metrics, analyzing trends, and resolving manufacturing and product issues in partnership with quality and R&D.
- Lead and support project execution by drafting charters, managing schedules, identifying risks, and coordinating with internal teams and external partners.
- Manage external collaborations and compliance by working with government agencies on grant reporting, overseeing technical partnerships, and ensuring adherence to ISO and GSR standards.
- Drive process innovation and problem-solving by developing new technologies and formulations, resolving technical issues, and supporting automation and process improvements.
- Support cross-functional initiatives by coordinating with R&D, manufacturing, and quality on product scale-up, technology transfer, and validation activities.
- Promote safety and team development by enforcing safety practices, mentoring staff, and fostering a culture focused on customer satisfaction, excellence, and engagement.
Qualifications:
- 5+ years in technical operations, product development, design transfer or a combination
- 5+ years in a regulated environment within pharmaceutical or medical device manufacturing
- Bachelor's degree in biomedical related field required, Master's degree in biomedical related field strongly preferred but not required
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