Job Description

Areas of Interest

Engineering/Maintenance, Health and Safety/Environment, Risk Management

Location(s)

Toronto - Ontario - Canada

Full Spectrum Lab Services from CBRE offers a professional suite of services to a variety of clients in the life sciences industry, including those in pharmaceuticals, biotech, medical devices, and genomics, as well as contract research organizations (CROs) and contract manufacturing organizations (CMOs).

Our comprehensive range of services includes laboratory consulting, real estate services, instrumentation repair and maintenance, full asset management, and more-covering the entire spectrum of life sciences facilities. With expertise across various life sciences categories, CBRE is a leader in managing highly-regulated spaces within the industry.

About the role

The purpose of this position is to lead the CBRE Quality Representatives staff on medium to large scoped client accounts. This role leads 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, ensures the integration and ongoing oversight aspects required by that QMS are appropriately implemented by the CBRE Quality Representatives. This position works with the client\'s Quality Assurance team leadership to support routine quality assurance and quality control deliverables. This role supports change, event & root cause analysis processes through review and/or approval actions. This role ensures all CBRE employees are qualified for the work they are performing. This position owns all quality agreements.

What you\'ll do

• Leads 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 or Quality Agreement.
• Delivers and implements the CBRE 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 and the client.
• Interfaces, partners, and interacts with 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 during review meetings.
• Appropriately raises and notifies CBRE and client management of quality and compliance issues.
• Responsible for the inspection readiness program for the site. Inspection readiness may include periodic CBRE self inspection, client self inspections, or any external agency inspections like the FDA.
• Leads audits as well as serve as the primary quality representative for CBRE 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
• Ensure all GxP service providers are qualified per the CBRE regulated vendor qualification process (as well as any client directed qualification program).
• Accountable for approving all quality agreements with third party service providers and ensuring the ongoing oversight of those vendors is performed.
• Responsible for the training and qualification program for CBRE employees. Ensures that all employees are qualified for the role they perform.
• Trains CBRE 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.
• Leads all aspects of the execution (maybe required to participate) and supervises the success of CBRE quality of service initiatives on the account for non-regulated services.
• Authors and negotiates terms of Quality Agreements with clients and vendors.
• Investigates deviations/events, issues and leads Corrective/Preventative Actions. Participates in creation and management of changes.
• Performs other duties as assigned.

Supervisory responsibilities

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 labor, 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 behaviors that are consistent with the company\'s values.

What you\'ll need

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 within Life Science Environment(s) preferred. Specialized training in quality assurance audits preferred. Previous supervisory experience a plus.

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. Green or Black Belt Six Sigma Certification preferred.

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.

Reasoning ability

Ability to solve sophisticated 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.
• 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.

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.

Why CBRE?

We offer comprehensive benefits such as health, vision and life insurance, 401k, personal time off, among others.

Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future

CBRE