Amgen Jobshttp://www.amgen.jobs2012-05-26 16:23:19.802826USAThousand OaksAuto req 15349BR Job Posting Title Dir Information Systems (Quality Lab Systems) Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director of Information Systems Quality Lab Systems (within OIS) will be responsible for the successful management and execution of all the IS activities supporting the Quality Control (QC) within the Operations Quality organization. The key focus area will be the leadership and management of our Quality Lab Systems Portfolio, which includes LIMS with Stability Management, LMES (Electronic Notebook) with Consumable Inventory Management, and CDS systems. The person in this role will lead the Corporate Quality Lab IS team that supports the AMGEN QC Network globally. The person will have direct client executive relationship management responsibility with Amgen Corporate QC executive as primary client, as well as site business executives as stakeholders of the delivered systems and solutions. This person will become part of the overall Global OIS Leadership team and will have opportunities to lead strategic issues and/or to help influence corporate/global wide directions within OIS. This position will be based in Thousand Oaks, California and travel at various times is anticipated to be approximately 20% to support globally distributed staff and portfolio execution. Specific Responsibilities are: • The Director will manage a staff of Lab Systems Analyst distributed globally across Amgen locations, in delivery of Lab Systems services utilizing and enhancing the Lab Systems Global Delivery Model and Business Practices. The Lab Systems portfolio spans across both Commercial and Clinical areas and includes a mix of facility expansions, systems upgrades and new construction projects. Oversight responsibilities will include individual project governance with stakeholders and service providers including business case justification, scope, schedule, resourcing, application of technology, reporting as well as portfolio level demand management, resourcing, reporting and prioritization with clients. • This person will be responsible for developing and driving the overall global Quality Lab Systems Project Portfolio, including the governance and budget strategies that can deliver the global portfolio. • This person will also be responsible for developing and driving a global IS Support Model (for day-to-day operations, software product roadmap, and life-cycle management) for the lab systems; one that will leverage the existing Global external partnerships, IS network and staff at each of the major Operations sites. • The candidate must be able to influence the development of business area strategy where appropriate and be expected to partner with key stakeholders to drive the lab systems roadmap and its’ evolution looking ahead to Quality’s strategy. • The individual will develop and chair the Amgen’s Lab Systems network through a cross site and cross functional team setting, and will participate in several Global QC forums representing the voice of Amgen Lab Systems network. • The individual will also manage key strategic supplier relationships from both product and services side as required. • The individual will ensure compliance with Amgen and industry practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies with supporting documentation and monitoring. • Continuously drive improvement processes & governance for IS in support of QC organization Basic Qualifications • Doctorate degree & 4 years of directly related experience OR •Master’s degree & 8 years of directly related years experience OR •Bachelor’s degree & 10 years of directly related experience • AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in Computer Science, Engineering, Life or Physical Sciences, or Business (MBA) • 12+ years of biopharma experience with 15+ years experience in operations/manufacturing/clinical manufacturing/IS, including cGMP regulated environments • 5 years of supervisory experience with demonstrated skills in staff motivation, coaching/mentoring and professional development. • Experience working cross-functionally and building collaborative working relationships; interfacing effectively with Operations and IS Senior and Executive Management to resolve issues • Excellent communication capabilities vertically and horizontally. • Ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making • Certified or experience in process improvement methodologies such as Lean/Six Sigma • Facilitation/ Planning / Negotiation / Coaching & Project Management skills • Results oriented, strong adherence to timelines and ability to maneuver in large corporate setting • Excellent ability to translate knowledge and build high performing teams • Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation. • Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering. • ERP experience is a plus.2012-05-16 19:08:38United StatesAmgenCalifornia15349BRCAThousand Oaks, CA28737808http://www.amgen.jobs/xml/28737808/jobUSAThousand OaksAuto req 11636BR Job Posting Title Dir Information Systems Career Category Information Systems Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Director Information Systems will act as the Operations Information Systems (OIS) leader supporting the Manufacturing of the Future initiative to include building of new manufacturing sites as well as modifications of existing facilities. Responsibilities Include: • Leading the application and evolution of Amgen Operations Information Systems S95 blueprint and technical architecture to the manufacturing of the Future facility requirements. • Accountability for delivering the OIS work streams in alignment with the larger program and Amgen IS organization. • Will form and manage strong relationships and work collaboratively with multiple areas across the enterprise to communicate, govern, and deliver the IS scope. • Providing technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS project manager oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives. • Influencing the development of business area strategy where appropriate. • Strong program / project management and leadership skills, including but not limited to the following: client interfacing and resolution of client concerns, developing and reporting project results, technical guidance of a project from concept to delivery, detailed project planning, vendor/contract management, system commissioning and validation, technical solution evaluation, schedule tracking. Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master’s degree & 8 years of directly related years OR - Bachelor’s degree & 10 years of directly related experience AND - 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications - Demonstrated working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and will direct efforts of automation & Information Systems integrators, vendors, contractors, and Amgen teams in the successful execution of efforts by using appropriate development methodologies to establish a Process Automation System, Manufacturing Execution System, IT infrastructure, and Systems and Data Integration that meets Operations' business requirements. - Demonstrated working knowledge on automation systems & manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation. - Direct experience with Shop floor Automation systems (DCS, PLC/SCADA, BAS), MES systems, Manufacturing IT infrastructure, and Plant Systems & data integration, and Information Management required. Experience with Emerson DeltaV, Rockwell PLC/SCADA/Batch, OSIsoft PI data historian, Werum PAS/X, MES and BMS is preferred. Experience in other areas of Information Systems supporting manufacturing business unit is a plus. - Demonstrated working knowledge of enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering. - ERP experience is a plus.2011-09-15 19:42:22United StatesAmgenCalifornia11636BRCAThousand Oaks, CA23645739http://www.amgen.jobs/xml/23645739/job