Looking to to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
探花合集 is seeking a Project Manager with expertise in quality assurance for medical devices and combination products. In this role, you will lead complex projects and quality initiatives, providing strategic guidance and support to global teams. You will play a key role in ensuring compliance with regulatory standards and driving the quality of deliverables across projects.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Lead and support global project teams, representing QA in sub-teams, quality board meetings, and development gate meetings.
- Provide quality oversight on assigned development projects, offering strong guidance and technical expertise.
- Develop and implement project strategies, including contingency planning and risk assessments, to ensure timely delivery of quality outcomes.
- Ensure alignment of project strategies with QA goals and compliance with cGMP guidelines and internal procedures.
- Manage interactions between QA and other departments, both internally and externally.
- Communicate project strategies, key issues, and critical updates to stakeholders and management in a timely manner.
- Contribute to contracts and QA agreements with third parties, approving project-specific amendments as needed.
- Lead or participate in global and cross-functional initiatives.
- Prepare and guide project teams for inspections, including Mock-PAI and PAI, as part of submission preparation processes.
Key Skills and Requirements:
- Strong understanding of quality standards and policies in drug product and medical device/combination product manufacturing and control.
- Experience with Health Authority inspections (e.g., FDA, EMA) and Notified Body inspections.
- Knowledge of regulatory requirements for submissions (e.g., INDs, IMPDs, NDAs, ANDAs, MAAs).
- Proven experience in combination product development and quality assurance or quality control.
- Familiarity with technical operations or equivalent experience in external companies.
- Demonstrated ability to support interdisciplinary teams and contribute to matrix teams with strategic thinking and quality awareness.
- Proficiency in computer systems, including MS Office and document management systems, with a willingness to learn new tools.
- Fluent in English (oral and written); proficiency in additional languages is a plus.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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