We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a Country Quality Lead to oversee and guide quality assurance activities for complex projects within the pharmaceutical industry, specifically in the diabetes therapy area. In this role, you will lead global project teams, ensure compliance with quality standards, and contribute to strategic initiatives. This position requires expertise in quality management, regulatory compliance, and cross-functional collaboration.
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 Quality Assurance (QA) in meetings and development gate reviews.
- Provide quality oversight and guidance on assigned development projects, ensuring compliance with cGMP guidelines and internal procedures.
- Develop project strategies, including contingency planning and risk assessments, to achieve quality deliverables.
- Manage interactions between QA and other departments, ensuring alignment and proactive communication of key issues.
- Represent QA in due diligence activities, providing quality assessments for potential in-licensing products.
- Contribute to contracts and QA agreements with third parties, including project-specific amendments.
- Prepare and guide teams for inspections, including Mock-PAI and PAI processes.
- Lead or participate in global and cross-functional quality initiatives.
- Coach and mentor team members, contributing to recruitment efforts as needed.
- Provide QA support for audits, inspections, and portfolio projects involving medical devices and drug-device combination products.
- Drive continuous improvement in GMP and QMS processes through interface meetings with relevant units.
Key Skills and Requirements:
- Strong understanding of quality standards and policies in drug substance, drug product, and medical device manufacturing.
- Experience with Health Authority inspections, particularly FDA and EMA, and knowledge of regulatory requirements for submissions (e.g., INDs, IMPDs, NDAs, ANDAs, MAAs).
- Broad experience in technical drug development, Quality Assurance, and/or Quality Control.
- Proven ability to lead interdisciplinary teams and contribute to matrix teams with strategic thinking and quality awareness.
- Familiarity with computer systems such as MS Office and document management systems, with a willingness to learn new tools.
- Fluent in English (oral and written); proficiency in the local site language is a plus.
- Educational background in a relevant field (bachelor's or master's degree) with significant experience in pharmaceutical quality or operations.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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