Reporting to the Director of Quality, or a VP Quality, the Senior Quality Manager of BD Caribe LTD - Biosciences provides direct management to technical and managerial staff in Cayey, PR. The role contributes to the definition of the Life Sciences strategy and determines the tactics required to achieve plant/business unit/function objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality organizational issues as well as business process effectiveness. Through stakeholder engagement; and people development; the Manager produces durable and industry leading results supporting key business drivers. Job Description BD Values We do what is right We take personal responsibility We anticipate and address the challenges of patients and customers globally We innovate and improve continuously We respect, collaborate, challenge and care about each other Primary Responsibilities Perform the function of BD Caribe, LTD - Biosciences Operations Management Representative: ensuring that the Quality System Requirements are effectively established and maintained; reporting on the performance of the Quality System to management and with executive responsibility for review and the development and implementation of the Quality Plan in conjunction with other Leadership Team members at the plant and home office. Manages the Quality Assurance, Quality Control and Quality Compliance staff and activities to support the transfer, manufacture and release of clinical and research products that meet established specifications. These activities include: inspection, testing for disposition, quality engineering support (QE/SQE), environmental monitoring, validation, material disposition, in-process product disposition, finished goods disposition, data collection/trend analysis, quality auditing, Quality/Compliance Training, complaint processing & investigation, quality record retention, quality documentation and change control process. Manages, coaches and develops a team that achieves the business and Quality Assurance, Quality Control and Quality Compliance department and associates goals. Participates in creating the department budget and pro-actively manages it to targets. Works in conjunction with other functional leaders to ensure CAPA activities (investigation/corrective and preventative action) are carried out in a timely manner. Creates and communicates trends analysis of quality indices within the plant and the home office. Though the review process identifies potential CAPAs and confirms effectiveness checks Foster an environment and practices of Quality /Continuous Improvement tools and education for the department and facility. Participates as a leader/trainer or coach for such activities. Participates / host investigations from regulatory agencies. Notifies Bodies and customers. Take the lead in developing, monitoring and reporting any necessary corrective action strategy. Participates in BDB or corporate program or product and process improvement teams. Promotes awareness of regulatory and customer requirements. Keep abreast of US and International regulations that effect our products. Actively communicates changes to management and staff and provides guidance on any needed modifications. Ensures modifications are carried out for continued compliance. Ensure that Internal Communication procedures are established that include the effectiveness of the Quality management System. Actively participate in the Daily Management System by attending, leading shift start up meeting, and providing appropriate metrics. Actively attend and participate in the ESC meeting and initiatives. Provide recommendations to support systems that continuously improve product / process quality availability, reduce cost and increase production capability. Perform other duties as required. Position Overview The Senior Quality Manager position is responsible for: developing, assuring that the organizational structure, responsibilities, procedures, processes, and resources for the business Quality Systems and implementation of Quality compliance are adequate to meet the needs of the WW business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies. Responsible for the development, implementation, and improvement of an effective quality system that meets appropriate WW Business, Division, Corporate, Government, and International Standards for efficacy, safety, quality, and customer satisfaction. Assures programs are consistent and in compliance with FDA Quality System Regulations, ISO 13485 and ISO 9000 standards for IVD, Medical Device, products in clinical, industrial and research applications as well as custom products designed for specific customers. Serves as Life Sciences Deputy to Quality Management Representative for Worldwide BD Biosciences. Has primary responsibility for regulatory inspections and compliance implementation. Works on complex problems where analysis of situations or data requires an evaluation of intangible, variable factors. Exercises judgment and decision making in developing methods, techniques, processes and evaluation criteria for obtaining results. Ensures that budgets and schedules meet BD Biosciences Systems targets and that changes are approved at appropriate levels. Will serve as a primary liaison; establishing rapport and working collaboratively with regulatory agencies as a representative of BD Life Sciences senior management. Deputy Management Representative: sets the direction and has responsibility / oversight for multi-site Quality Systems for the new product development, manufacture, transfer, release and support of reagent products. Establishes and leads business and functional and strategies / objectives. As the business deputy assures compliance and the appropriateness of the Quality Systems by partnering with other functional leaders at each site. Assures the organizational structure and talent of the Quality / Regulatory Compliance groups are capable of meeting business and compliance requirements. Develop the operating and capital budgets for Quality at the Cayey site. Must keep current with US and International regulations affecting product development, manufacturing and WW commercialization. Interprets and communicates changes to the business. Carries out Management responsibilities such as the hiring, job assignments, performance planning and talent development, salary actions, performance reviews, and termination recommendations. Perform other related duties and assignments as required. Excellent analytical, technical, and problem solving skills (TQM or Six Sigma experience preferred). Excellent and experienced meeting and presentation skills (presents at Trade Shows / Conferences). Ability to perform multiple tasks / large projects and to prioritize work load for function. Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties Ability to work in and to direct teams to obtain results. Knowledge and experience in financial management, planning, and organizational skills. Self-motivated/directed. Supervision Coordinating and directing the activities of exempt and/or nonexempt associates Education and Experience Requires a bachelors degree in Microbiology, Molecular, Cell Biology, scientific or engineering discipline. Individuals with an advanced degree preferred. A minimum of 9 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm. A minimum of 3 years directly managing Quality professionals. Professional certification is preferred (i.e., RAC, CQA, CAE, SQE, CQM, Six Sigma, etc.) Mental Demand Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Manage stressful situations Physical Demand Occasionally, the work requires seeing (far vision/visual color discrimination) and standing. Frequently, the job requires walking and sitting. Constantly will have activities which require fingering, talking, hearing and seeing near vision. Working Environment The work is performed constantly inside the building. Does not present risks and discomforts in the employees physical surroundings.
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