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The Analytics Society of INFORMS is focused on promoting the use of data-driven analytics and fact-based decision making in practice. The Society recognizes that analytics is seen as both (i) a complete business problem solving and decision making process, and (ii) a broad set of analytical methodologies that enable the creation of business value. To this purpose, the Society promotes the integration of a wide range of analytical techniques and the end-to-end analytics process. It will support activities that illuminate significant innovations and achievements in specific steps and/or in the execution of the process as a whole, where success is defined by the impact on the business.

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JOBS OF INTEREST TO ANALYTICS

  • Emeryville, California, Quality is the primary guiding principle at Zogenix. It is the foundation on which all functions and activities are performed. Excellence in the management of quality is fundamental and the foremost aspect upon which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective quality, development, operations, and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases. The Senior Director, Clinical Quality will provide strategic direction, operational delivery and Quality oversight of Zogenix's Clinical Development programs and ensure compliance with global GCP regulations. The role will partner with Clinical Operations and Clinical Science to provide strategic, tactical, and operational guidance regarding GCP compliance with current pharmaceutical laws and regulations. The Sr Director will be instrumental in integrating quality throughout all steps of the clinical study process, including monitoring, auditing using risk assessments, and trending key metrics to drive continuous improvement in compliance and quality. In addition to the primary GCP Quality oversight responsibilities, this role will also support GLP and GVP activities with respect to Quality oversight. This leadership role will sit on the global Quality Leadership team at Zogenix and will lead a team of Quality experts. The Quality team supports Zogenix throughout the product development and commercial life cycle by providing appropriate knowledge/expertise/oversight and communicating effectively with internal and external stakeholders to ensure that Zogenix operates within relevant regulations. PLEASE NOTE – this is a REMOTE position Responsibilities Build, develop and manage a high performing Quality team with focus on retaining and developing key talent. Ensure appropriate resources to meet all business objectives. Lead efforts to develop and implement full clinical site qualification program through development of GCP auditing system and partnership with Clinical Operations team. Perform CRO supplier risk assessments in support of QA Vendor qualification program. Establish audit plans and annual CQA audit plan. Execute GCP and GLP compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risks. Provide leadership and guidance to Quality teams for oversight of GCP, GLP, and PV activities at Zogenix and its investigator sites and contract research organizations for clinical and nonclinical studies; collaborate with Clin Ops and external partners to effectively and efficiently set up the overall GCP oversight programs. Maintain an effective Quality governance and continually improve governance to meet business and compliance needs. Serve as a subject matter expert to the company on GCP Quality related issues by communicating proactively and effectively with cross-functions at all levels.  Collaborate with Clinical Science and Clinical Operations functions to confirm adherence to GCP compliance through all stages of clinical trial conduct including but not limited to core study execution documents, clinical trial sponsor oversight, issue escalation, internal/external audit support. Review supportive clinical trial documents (manuals, study plans) for compliance with regulations. Ensures appropriate CAPAs and risk mitigation activities as necessary. Implement and maintain SOPs pertaining to Quality of GCP related activities and overall QMS with focus on development programs. Effectively identify quality and compliance issues, actively resolve issues, recommend solutions and provide Clinical QA guidance across functions. Actively  lead and participate in inspection readiness activities and prepare/train other entities for a successful inspection. Host and participate in relevant external and regulatory authority inspections. Respond to and resolve issues relating to inspection findings. Provide GCP/GLP training to functional areas and ensure the content satisfies regulatory requirements and GCP guidelines.. Effectively communicate key quality metrics and build a culture of quality across the organization. Serves as a strategic partner to internal and external business partners in driving innovative approaches for issue management within clinical development and credible thought leadership regarding CAPA and processes. Define and operate within approved operating budget Support the Company's project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner 50% Travel (domestic and international) Requirements Bachelor's Degree in a life science-related discipline or related field Advanced degree (PharmD or PhD) preferred 12+ years of experience in the pharmaceutical/ biotechnology industry. Broad experience across Quality, PV, Regulatory affairs and Development desired. Minimum 8 years of comprehensive experience in GCP Quality Assurance with 5+ years in management role Experience in global settings including interaction with various Health authorities highly desired Strong proven hands-on experience with a variety of GCP compliance matters and contractor management in the bio/pharma industry Experienced in handling multiple heath authority inspections (FDA, EMA etc) Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs Strong knowledge of US and other major global (ICH, EU, Asian) Clinical regulatory compliance requirements Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards Ability to multi-task in a very fast-paced environment, with maturity and experience in making high impact decisions and communicating effectively with senior executives. Must be able to effectively collaborate with peers and comfortable working in a matrixed team Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills) Excellent project management and organization skills is a must Excellent communication skills (verbal and written) and interpersonal skills.
  • Frisco, Texas, Head of Business Development, Food & Health Technologies, GEA Food Solutions North America, Inc., Frisco, TX. Lead process improvement projects using business tools such as ERP, mobile service software, and support software packages. Develop analytically based insights and business recommendations to drive best practices, growth, profitability, and competitive success. Identify, align and prioritize potential change areas, based on performance, customer and business needs. Support the service organization’s needs with KPIs that measure and drive sales performance. Work closely with colleagues across the service organization including IT, Sales, Operations, and Finance to drive improvement in quality, volume, profitability and ensure alignment of company goals. 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. MINIMUM REQUIREMENTS : Bachelor’s degree, or foreign equivalent degree, in Business, Engineering, Science or related field, and four (4) years of related work experience. Must have four (4) years of experience with/in: Using business tools ERP and CRM platforms to manage projects and generate reports; Developing KPIs that measure and drive sales performance for field service teams; Designing, implementing and monitoring strategic marketing/sales plans; and Using analytically based insights to develop new go-to-market strategies and drive business growth. Up to 25% travel required. Please email resumes to Patricia Diaz at Patricia.Diaz@gea.com with reference job code TX0014.
  • Londonderry, New Hampshire, Job Description:    The Quality Engineer will support and interface with Program Management, Supply Chain, Manufacturing and Engineering personnel to support the establishment and implementation of effective process controls, geared toward risk mitigation. Proactively monitor, analyze, report and participate in the improvement of process and product performance employing proven Six Sigma methodologies.  Lead failure analysis and corrective action efforts using complex problem solving methods to drive the development of technical solutions. Manage product qualification, monthly testing and test report generation. Review and verify applicable contractual/Customer requirements and ensure these are known and translated as warranted, into operational plans and test procedures. Support through use of data analytics, the verifying and validating of process, methods and associated equipment capability. Participate in the verification, validation and acceptance of proposed product design and process changes. As needed, participate in the review and disposition of nonconforming product. As required, support the training, mentoring and coaching of lab and inspection personnel in the technical requirements of product. Represents the organization when interfacing with Customers and their agents (DCMA) throughout the production phase of their programs. Assists in the conducting of internal audits of the Quality Management System. Experienced professional with proficient knowledge of job area and practical knowledge of project management. Manage projects or processes with general supervision. Communicates with contacts inside and outside of own department to explain and interpret operational processes, practices, and procedures. Recommends enhancements to systems and processes. Works to achieve operational targets for specific programs and projects with moderate impact on departmental results. Basic Qualifications: Requires proficient knowledge of job area typically obtained through advanced education combined with experience. May have practical knowledge of project management. Bachelor’s Degree and minimum 4 years of prior relevant experience or 2 years post-Secondary/ Associates Degree and a minimum of 8 years of prior related experience. Graduate Degree and a minimum of 2 years of prior related experience.     Bachelor’s Degree and minimum 4 years of prior relevant experience or 2 years post-Secondary/ Associates Degree and a minimum of 8 years of prior related experience. Or Graduate Degree and a minimum of 2 years of prior related experience.
  • Londonderry, New Hampshire,   Job Description: L3Harris’ IVS Division is a world leader in the development and production of advanced night vision and electro-optical systems and components, and supports all branches of the United States Military, law enforcement, first responder agencies, allied nations, and consumers. Our Londonderry, New Hampshire location is seeking a Quality Engineer III.   The Quality Engineer III will support and interface with Program Management, Supply Chain, Operations and Engineering personnel to support the establishment and implementation of effective process controls, geared toward risk mitigation. Proactively monitor, analyze, report and participate in the improvement of process and product performance employing proven Six Sigma methodologies.  Lead failure analysis and corrective action efforts using complex problem solving methods to drive the development of technical solutions. Manage product qualification, monthly testing and test report generation. Review and verify applicable contractual/Customer requirements and ensure these are known and translated as warranted, into operational plans and test procedures. Support through use of data analytics, the verifying and validating of process, methods and associated equipment capability. Participate in the verification, validation and acceptance of proposed product design and process changes. As needed, participate in the review and disposition of nonconforming product. As required, support the training, mentoring and coaching of lab and inspection personnel in the technical requirements of product.  Represent the organization when interfacing with Customers and their agents (DCMA) throughout the production phase of their programs. Assist in the conducting of internal audits of the Quality Management System.   Basic Qualifications: Bachelor’s Degree in Engineering, Business or Technical discipline required with 5-8 years related experience,   Preferred Qualifications: Experience working in a high volume optical and/or electro-mechanical manufacturing organizations with focus on government, military and law enforcement products. Knowledge of thermal technology, lasers, optics, and related test procedures or equipment is desired, as is a proven track record planning, communication, leadership and problem solving. Experience in lean manufacturing and working knowledge of ISO 9001:2015 Quality Management Systems is highly desired. Six Sigma Green Belt certification required, with a minimum of 3 years practical application.  Black Belt certification is a plus. Must be a self-starter and able to adjust quickly to changing priorities and assignments. Intermediate/advanced SPC/Data analysis skills and proven ability to perform DOE, FMEA, ANOVA and Gage R&R analysis is required. Bachelor’s Degree in Engineering, Business or Technical discipline required with 5-8 years related experience,  
  • Dallas, Texas, Advisory Senior Associate, Human Capital Management (Multiple Positions), PricewaterhouseCoopers Advisory Services LLC, Dallas, TX. Assist clients implementing and effectively utilizing multiple HCM offerings to solve their business problems in the areas of finance, operations, human capital, customer, and governance, risk and compliance.  Help clients assess the benefits of upgrading or replacing their human resource systems. Assist organizations by using enterprise technology to achieve their digital technology goals and capitalize on business opportunities. Analyze complex business issues from strategy to execution. Demonstrate in-depth technical expertise. Help identify and research opportunities on new/existing clients. 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.    MINIMUM REQUIREMENTS : Must have a Bachelor’s degree or foreign equivalent in Business Administration, Management Information Systems, Data Analytics, Computer Science, or a related field, plus three (3) years of related work experience; OR a Master’s degree or foreign equivalent in Business Administration, Management Information Systems, Data Analytics, Computer Science, or a related field, plus one (1) year of related work experience. Must have at least one year of experience with each of the following: - Assisting to design and implement Workday applications-based solutions and modules; - Designing and deploying technical components for successful Workday Solutions such as RICE and/or DBA; - Configuring Workday software to meet technical requirements to develop client solution; - Analyzing large, complex data sets using custom SQL queries to recognize client concerns; and, - Using complex SQL queries and macros to create first step in solution process. Travel required up to 80%.   Please apply by mail, referencing Job Code TX3008, Attn: HR SSC/Talent Management, 4040 West Boy Scout Boulevard, Tampa, FL 33607.

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