Quality Systems Specialist (m/f/d)

REFERENCE NUMBER:

413487/1

MY DUTIES:

-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 and GMPs
-Understand and ensure that applicable regulatory requirements are incorporated into the global PQS
-Enable and balance out the global PQS to meet evolving business and regulatory needs, ensure sufficient flexibility for TR address and resolve identified issues for the TR&D stakeholders during the global review of the requirements
-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 and represent TR&D stakeholders in global non-product related (Quality) projects

MY QUALIFICATIONS:

-B.S. or B.A. degree (preferably in relevant scientific discipline)
-Profound 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 and 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
-Ability to execute 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)

MY BENEFITS:

-Reputable company

ABOUT HAYS:

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.

MY CONTACT AT HAYS:

My contact person
Yves Fabien Deschamps

Reference number
413487/1

Contact
E-Mail: [email protected]