Beschreibung
Quality System Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Serve as IMP Quality Systems SME to collaboratively set direction, implementation and enhancement of GMP phase adapted PQS and global quality business processes with sufficient flexibility for operational and development needs
- Shape and coach phase appropriate/risk-based compliance
- Understand and ensure that applicable regulatory requirements are incorporated into our global PQS
- Enable and balance out our global PQS to meet evolving business and regulatory needs, ensure sufficient flexibility for TR&D
- Lead and collaborate on development of global documents consistent with the overall global PQS document master plan; address and resolve identified issues for the TR&D stakeholders
- Oversight and support of the implementation of the global PQS documents at the TR&D stakeholders
- Lead, facilitate and/or manage global IMP Quality non-molecule PPM projects
- Be the first point of contact for global compliance challenges and build key partnerships and collaborate with the different quality functions and the TR&D stakeholders
- Interpret global regulatory requirements, company-wide GMP systems/business processes to apply to the development pipeline
- Maintain awareness of new regulations and monitor emerging regulatory trends to assess impact on the clinical quality systems and the business and evaluate impact to established Quality Systems
- Evaluate existing systems for monitoring compliance and effectiveness of IMP quality systems and business processes
- Build key partnerships and collaborate with corporate quality, site quality, and stakeholders to ensure the achievement of goals
- Perform other related duties that may be required based on corporate, PTD, IMP Quality goals and business needs
- Be the first point of contact for global compliance challenges and build key partnerships and collaborate with the different quality functions and the TR&D stakeholders
- Support the local stakeholders for continuous improvement of the global as well as their local quality system and processes
- Ensure our stakeholder awareness of new regulations and regulatory trends for IMPs and support the implementation of it
Main qualifications
- B.S. or B.A. degree (preferably in relevant scientific discipline)
- In-depth relevant business and/or technical experience in the pharmaceutical or biopharmaceutical industry preferably in clinical (IMP) development
- Current working knowledge of cGMPs, ICH guidances, and regulatory and industry technical standards relative to clinical (IMP)development, understanding of international GMPs, regulations and standards is a plus
- Previous experience with development of quality standards and processes
- Proven track record of successfully planning, implementing, and tracking of global/highly complex projects on time and within budget
- Lean six sigma, operational excellence, process mapping/improvement experience desired
- Strong collaboration and influencing skills across cultures, countries, and organizational levels
- Excellent communication (verbal and written), interpersonal and organizational skills are essential.
- Some (5-10%) travel required (will vary based on projects/role)
Main advantages:
- You will work in an international environment
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Emina Mustafic
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