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Job #02555

About our client Our client is a clinical stage company. The company discovers, develops and commercializes new antibody-based therapeutic and preventative products to meet the significant under-served medical needs. Their unique antibody-based products are produced through the cultivation of genetically modified green plants. Position Location Quality Systems Leader Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Create a Quality Management System (QMS) to ensure the client’s control over all aspects of manufacturing of proteins and glyco-proteins for use in pre-clinical and early clinical studies 2) Ensure appropriate compliance with the GMP and applicable ISO and ICH guidelines 3) Create the documentation required for the client’s QMS 4) Administer the creation, use, change and archiving of documents used in quality assurance and quality control in connection with all manufacturing processes and products for use in pre-clinical and clinical testing 5) Assist in the creation of a system of documentation for the acquisition and transfer of technology and research materials 6) Identify regulatory issues in pre-clinical and clinical product manufacturing documentation 7) Interact with the client’s Regulatory Affairs personnel and consultants in resolving issues affecting product development (as required under applicable regulatory rules and guidelines under QMS) 8) Demonstrate the client’s control of the facility by documenting the company’s compliance with applicable regulatory rules and guidelines 9) Interact with the client’s manufacturing and regulatory affairs personnel and consultants in identifying QMS issues affecting the design, construction and qualification of the pre-clinical and clinical supplies manufacturing facility 10) Lead audits of contract research and manufacturing organizations involved in testing/manufacturing products 11) Assist in planning and budgeting for the costs of QMS implementation and maintenance, including training of key personnel 12) Develop or (when appropriate) assist in the development of a training program for personnel whose work will be governed by the QMS 13) Interact with the client’s senior staff and consultants to coordinate and administer the client’s activities to comply with regulatory and company requirements for the documentation and preservation of relevant laboratory records 14) Attend at the client’s expense at least 2 regional and 1 national meeting per year to stay current with industry development in Quality Systems Management, GXP and ICH guidelines Requirements 1) B. Sc./BA 2) 4+ years of experience in quality assurance/quality control in a pharma/biotech/medical device company 3) Knowledge and experience in cGMP requirements for drugs 4) Drug manufacturing experience preferred 5) Updated knowledge of GXP and ICH guidelines (as it relates to protein research, bioprocess development and scale-up to commercial manufacturing operations)