The purpose of this position is to lead the CBRE Excellerate Quality Representatives staff on medium to large scoped client accounts (may include multiple accounts/clients). This role manages the creation, revision, and enforcement of all aspects of the CBRE Excellerate Quality Management System (QMS), or in situations where CBRE Excellerate operates within the client's QMS, ensures the integration and ongoing oversight aspects required by that QMS are appropriately executed by the CBRE Excellerate Quality Representatives. This position interfaces with the client's Quality Assurance team leadership to support routine quality assurance and quality control deliverables. This position supports change, event & root cause analysis processes through review and/or approval actions. This role ensures all CBRE Excellerate employees are qualified for the work they are performing. Lastly, this position is responsible for ensuring all master service agreement and quality agreement deliverables are executed per those respective contract terms.
* Manages the day-to-day Quality and Compliance Team operations at one or more account sites. Monitors operations at each site and determines compliance status with regards to local and global regulatory standards as well as client specific requirements as defined in the master service agreement (MSA) or Quality Agreement.
* Delivers and implements the CBRE Excellerate compliance program and/or the client's compliance program. Attends Quality Forum monthly meetings to provide in-depth explanations for monthly reports and department metrics. Leads and participates in continuous improvement objects for both CBRE Excellerate and the client.
* Interfaces, partners, and interacts with both CBRE Excellerate and the client's functional areas and leadership teams. Appropriately communicates quality and compliance initiatives and/or issues across the functional areas impacted. Responsible for reporting Compliance (among other quality and business metrics) status to the client during review meetings. Appropriately escalates and notifies CBRE Excellerate and client management of quality and compliance issues.
* Responsible for the inspection readiness program for the site. Inspection readiness may include periodic CBRE Excellerate self-inspection, client self-inspections, or any external agency inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality representative for CBRE Excellerate's operations during external agency or client audits. Accountable to the client and/or agency for audit observations and the associated corrective measures.
* Responsible for the vendor management program for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE Excellerate regulated vendor qualification process (as well as any client directed qualification program). Accountable for approving all necessary quality agreements with third party service providers and ensuring the ongoing oversight of those vendors is executed.
* Responsible for the training and qualification program for CBRE Excellerate employees. Ensures that all employees are qualified for the role they perform.
* Trains CBRE Excellerate account personnel on the use of elements within the Quality Management System. Ensures the QA staff is qualified and delivering on the objectives of the QMS, annual quality plan, and the quality agreement with the client.
* Oversees the execution (may be required to participate) and tracks the success of the quality of service initiatives on the account for non-regulated services.
* Authors and negotiates terms of Quality Agreements with clients and vendors.
* Oversees vendor management program and qualify GxP vendors, as needed."
* Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in creation and management of changes.
Other duties as assigned:
* Provides formal supervision to individual employees supporting the account (may involve multiple clients/accounts).
* Approves subordinate's recommendations for staff recruitment, selection, promotion, advancement, corrective action and termination.
* Effectively recommends same for direct reports to next level management for review and approval.
* Plans and monitors appropriate staffing levels and utilization of labour, including overtime.
* Prepares and delivers performance appraisal to direct reports.
* Mentors and coaches team members to further develop competencies and robust succession capabilities.
* Leads by example and models behaviours that are consistent with the company's values.
* Bachelor's degree in Biology, Microbiology, Chemistry, or Engineering; or equivalent related work experience. Minimum 5+ years related work experience required. Previous experience within a quality organization within Life Science Environment(s) preferred. Specialized training in quality assurance audits preferred. Previous supervisory experience a plus.
* FDA, ISO, or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law. Green or Black Belt Six Sigma Certification preferred.
* Ability to comprehend, analyse, and interpret the most complex business documents. Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style. Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.
* Comfortable meeting and engaging with new people.
* Warm and engaging demeanour. Ability to assess circumstances, empathize and offer help.
* Requires in-depth knowledge of financial terms and principles. Ability to calculate complex figures. Ability to forecast and prepare budgets. Conducts financial/business analysis including the preparation of reports.
* Ability to solve advanced problems and deal with a variety of options in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.
* Experience with Desktop publishing, Microsoft Office Suite and Online Help. Previous experience with SAP Track wise, Regulus, and/or CMMS systems.
* Formal training with lean manufacturing, Six Sigma, 5S programs (among others) preferred.
* "Previous oversight of training and qualification programs within a regulated environment preferred.
* Significant experience and knowledge of Quality and Compliance Systems within Life Science Environment(s)
Quality auditing experience preferred
Decisions made with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results. Responsible for setting department deadlines. Errors in judgment may cause long-term impact to co-workers, supervisor, department and/or line of business.
Job added on 08 November 2019. Apply before Tue, 07 Jan 2020, 23:59 to qualify.