Under general direction, represents the primary relationship between our Client Quality representatives and CBRE. Responsible for the development and implementation of the GWS SRFS (SPECIALTY & REGULATED FACILITY SOLUTIONS) Quality Management System managing the alignment to the clients Teams and CBRE corp Quality Management Systems. Tracks and measures LS client team Audits and following investigation / action plans assuring services appropriate to the Life Sciences market. Evaluates, selects, implements and actualizes Best Practices across the Life Science portfolio. Provides understanding and use of the customer satisfaction assessment process, the integration and reporting of on-going process measurements, and control plans. Oversees Client team CAPA / QI events for CBRE deliverables as well as provide consultation and direct line management for Client Site Team Quality Mangers / Directors.
For quality and Compliance concerns, provide for a single point of contact between the site team (Account) Quality Mgrs / Directors, CBRE enterprise GWS team and CBRE Corp Quality, including event escalation.
QMS Management, Responsible for the development, communication and management of the CBRE SRFS (SPECIALTY & REGULATED FACILITY SOLUTIONS) Quality system. Implement CBREs Quality Framework. Assure alignment with the Corp Quality strategy, harmonizes each CBRE Client site quality plans.
SOP Management, Responsible for leading the compliance aspects of process standardization and harmonization for CBRE concerns engaging CBRE Corp leaders and quality systems.
Compliance to Regulations. Provide the Site Quality Mgrs / Directors guidance on regulatory impact and approach across the business needs based on Regulatory direction and Site team scope responsibilities.
Document Management; provide corp infrastructure teams direction for Life Sciences regulatory document needs.
Compliance Communication, Keep regular dialog with Client QA leadership and CBRE site teams (Accounts) regarding regulatory and compliance status, changes and innovation. Leading this global Community of Practice (CoP) for Quality & Compliance.
Training Compliance, work with Site Team Quality Mgrs / Directors and CBRE Corp quality teams to assure training plans, gap analysis, training attendance and training records are adequate, updated and properly recorded.
Support Site team Quality Mgrs /Directors in the delivery of Vendor and internal Audits, CAPA investigations and program goals / performance.
Document distribution & Control; Assure compliance documentation is managed per CBRE and GMP policy, challenge inefficient practices and sell change to the organization.
Researches, creates, and aligns quality initiatives with current International Standards Organization 9001 and 9002, Food and Drug Administration, MHRA, and other pertinent regulatory body requirements as they pertain to quality.
Provides supervision for the preparation of unique site level quality initiatives, quality process development, and documentation in support of customer validation support.
Develops a benchmarking and analysis process for use in assessing and improving services provided to Life Sciences Client base.
Measure and trend Site Team Quality Mgrs / Directors vendor audits of CBRE site team partners as well as CBRE Corporate support groups and partners as required.
Maintains a focus on customer satisfaction and the quality of performance providing quarterly measure and reports. Acts as the customer advocate, interface, and point of contact for quality and customer satisfaction of CBRE Life Science site teams.
Facilitates, manages, tracks, and reports the status of all SRFS (SPECIALTY & REGULATED FACILITY SOLUTIONS) deployments and initiatives with assistance and resources from the CBRE Client leadership teams. Maintains a deployment calendar of all quality initiatives.
REQUIREMENTS:
Bachelor's Degree in Quality Management, Business, Engineering, related field of study, or equivalent work experience.
Broad knowledge of facility systems and operations usually acquired experience in the field.
Ten years of experience and accomplishment while operating in regulated environments.
Presents demonstrable knowledge of ISO and FDA / MHRA regulation and GAMP guidelines.
Experience or certification for regulatory type audits. Demonstrated knowledge of Pharmaceutical, Biotech, and Medical Device industry products and services.
Broad knowledge of business processes used to plan, deliver, and support the organization’s products and services (special emphasis on experiences within the organization’s or industries Facility Management offerings, including those related to products, systems, and services).
Excellent interpersonal and communication skills (includes working with customers and all executive level relations), organizational skills, project planning and management, team building, and experience with quality management and measurement processes and tools.
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