Job Description

RESPONSIBILITIES

Under minimal supervision, manages the creation, revision, and enforcement of all aspects of the CBRE Quality Management System (QMS), or in situations where CBRE operates within the client's QMS, facilitates the integration and ongoing oversight aspects required by that QMS. This role actively participates with the maintenance of the quality of services (non-regulated) CBRE provides the client. This position interfaces with the client's Quality Assurance team members to support routine quality assurance and quality control operations. This position supports change, event & root cause analysis processes. This role is responsible for creation, revision, and oversight of the training programs, inspection readiness programs, and vendor management programs. This role also participates in CBRE and/or the client's continuous improvement (CI) agenda.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Interfaces with the client's Quality Assurance team members to manage the routine creation, revision, and enforcement of all aspects of the CBRE QMS; or in the case where CBRE operates under the client's QMS, assists with the integration and routine oversight of the client's QMS stated requirements. Ensures that CBRE personnel are maintaining compliance to the QMS and all local/global regulatory requirements.

Performs all service level agreement (SLA) and/or Quality Agreement responsible Quality Assurance and/or Quality Control tasks. Supports change, event & root cause investigation processes.

Manages the training program for the site, while ensuring compliance with the QMS and all local/global regulatory requirements for the scope of work defined in the SLA and/or Quality Agreement. Management of the training program includes but is not limited to: facilitation of course creation & revision, course instruction & remediation, coordination of the training schedule, maintaining employee training files, program and class financials, periodic metric reporting and completion compliance as defined in the SLA and/or Quality Agreement.

Manages the inspection readiness program for the site, while ensuring compliance with the QMS and all local/global regulatory requirements for the scope of work defined in the SLA and/or Quality Agreement. Inspection readiness may include periodic CBRE self inspection, client self inspections, or any external agency inspections like the FDA. Management of the inspection readiness program includes but is not limited to: facilitation of inspection planning, executing, reporting, appropriate escalation/notification to management, closing & executive summaries, as well as tracking and evaluating the effectiveness of any performed remediation by the audited party.

Manages the vendor management program for the site, while ensuring compliance with the QMS and all local/global regulatory requirements for the scope of work defined in the SLA and/or Quality Agreement. Vendor management program facilitation will include but not limited to: creation & revision of the vendor management procedure & risk classification procedure, vendor inspections, vendor classifications, on-boarding, performance monitoring, metric reporting, and termination.

Supports CBRE and/or the client's CI agenda. Supporting the CI process may include but not limited to: proposing Cis, participating on CI steering teams, evaluating Cis for feasibility/impact/priority, implementing Cis, and evaluating CI effectiveness.

Participates and/or leads initiatives associated with delivering excellent customer service and quality services for all the non-regulated services CBRE provides the client per the SLA.

Authors and negotiate 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.

Performs other duties as assigned.

SUPERVISORY RESPONSIBILITIES

No formal supervisory responsibilities in this position. Provides informal assistance such as technical guidance, and/or training to coworkers. May coordinate and assign tasks to co-workers within a work unit and/or project.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE

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 preferred. Specialized training in quality assurance audits preferred.

CERTIFICATES and/or LICENSES

FDA, ISO, or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law.

COMMUNICATION SKILLS

Ability to comprehend, analyze, 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 demeanor. Ability to assess circumstances, empathize and offer help.

FINANCIAL KNOWLEDGE

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.

REASONING ABILITY

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.

OTHER SKILLS and ABILITIES

Experience with Desktop publishing, Microsoft Office Suite and Online Help. Previous experience with SAP, Trackwise, Regulus, and/or CMMS systems.

Knowledge or formal training with lean manufacturing, Six Sigma, 5S programs (among others) preferred.

Knowledge of Quality Systems and Compliance within Life Science Environment(s).

Auditing experience in a regulated environment.

SCOPE OF RESPONSIBILITY

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.

SAFETY