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Leader of the BCR (Biological Critical Reagent) Netherlands,  

Posted on : 15 May 2017

Project Description

Leader of the BCR (Biological Critical Reagent) Hub-QUA005699DescriptionThe departmentQuality Operations at MSD Biotech Oss (around 100 people) has the following five sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents (BCRs). The Quality Department must ensure adequate quality systems are in place to support the manufacturing, packaging, testing, storage, and distribution of products according to our manufacturing division s Policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.The BCR Hub (around 20 employees) is responsible for supporting Biological Critical Reagent programs within the Biologics franchises and for managing the complete life cycle of reference materials, control samples and other materials used in support of release and stability testing of biological products. Next to that the BCR Hub is responsible for: " Supporting transfer of BCRs of new Biological products from our Manufacturing Division Commercialization / our Research Laboratories to the BCR Hub; " Supporting complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of BCRs within the global Biologics franchises; " Supporting distribution (in time delivery) of BCRs to MSD laboratories, contract laboratories and regulatory agencies.For more information about MSD Biotech, please watch the video below. positionReporting into the Executive Director Quality Operations the BCR Hub Lead must lead the hub to successfully supply compliant BCRs in a competitive way. The BCR hub is undergoing a transformational change and in parallel the hub must also meet growing supply demands. The change is based on five elements, i.e.: " Planning; " Execution and measuring success; " GMP compliance improvement; " Training people and building best teams; " Vendor management.The BCR Hub Lead must be capable of successfully implementing this change.QualificationsDesired skills & Experience: " Master s/ PhD degree in biological/ pharmaceutical sciences, biochemistry or biochemical engineering; " At least 10 years of relevant experience in Quality Operations in a pharmaceutical or biotechnological environment; " Proven track record in planning, executing and measuring success, GMP compliance improvement and vendor management; " Broad analytical knowledge in the field of BCR analysis; " Strong GMP and MPS Lean knowledge and thinking; " Strong process thinking skills, business process improvement skills (also strong in coaching how to optimize business processes) and a production mentality: " Thorough understanding of end- to-end supply chain/ S&OP processes, planning processes and customer demands; " Strong analytical and technical skills; " Well-developed coaching & people development skills; " Strong leader with mature and exemplary interpersonal skills; " Strong communication skills on operational/ local, tactical as well as strategic/ senior management level; " Excellent oral and written communication skills in English and a strong preference (or willing to learn) for Dutch.About MSDMSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.MSD. Be well. For more information, visit our website: www.werkenbijmsd.nlA good place to workOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.InformationFor more information about the position, please contact Joost van Zutven, Executive Director Quality Operations Biotech Oss, by phone: +31 (0)412  662251.ApplicationIf you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Quality Operations Job Title:Leader of the BCR (Biological Critical Reagent) HubPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Biochemistry, Biotech, Engineer, Law, Scientist, Science, Engineering, Legal


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