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Quality Solutions Lead
As a Quality Solutions Lead within PDQ, you will collaborate with cross-functional teams to design and execute fit-for-purpose quality solutions, ensuring a robust and regulatory-compliant Quality Management System (QMS) in China. You will provide technical expertise, drive quality culture, and partner with stakeholders to accelerate the delivery of medicines and healthcare solutions.
Responsibilities
- Deliver quality solutions that meet regulatory standards, including regulatory intelligence, process design, and continuous improvement.
- Ensure QMS excellence by managing process integrity, implementing new technologies, and overseeing performance metrics.
- Engage and influence stakeholders across the business to sustain and evolve the QMS.
- Manage vendor service agreements and oversee contractors.
- Perform data analysis to identify systemic findings and support quality insight needs.
- Act as a technical consultant, applying methodologies like business process improvement and change management to complex initiatives.
Requirements
- Master's or Bachelor's degree in a scientific or quality-related field.
- Demonstrated applied knowledge of regulatory requirements in GCP, with preference for pharmacovigilance (GVP) or medical device quality expertise.
- Strong strategic insight, critical thinking, and data storytelling skills.
- High learning agility and a proactive, risk-based approach.
- Experience in data analytics and influencing cross-functional teams.
Neugierig, hier zu arbeiten?Dann bewirb dich gleich für den Job bei Roche in Österreich.
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