Quality & Compliance Associate Manager- Life Sciences
직무 ID
14377
게시됨
24-04-2021
서비스 라인
GWS Segment
역할 유형
풀타임
RESPONSIBILITIES  

The purpose of this position is to lead the CBRE Quality Representatives staff on low to medium scoped client accounts. This role will oversee 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 executed by the CBRE 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 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.


ESSENTIAL DUTIES AND RESPONSIBILITIES  

Oversees the day-to-day Quality and Compliance Team operations at one account sites (may also support CBRE corporate QA initiates not client specific). Monitors operations at the 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.

Executes the CBRE compliance program and/or the client's compliance program. Leads and participates in continuous improvement objects for both CBRE and the client.

Interfaces, partners, and interacts with both CBRE and the clients 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 CBRE and/or the client during review meetings. Appropriately escalates and notifies CBRE and client management of quality and compliance issues.

Executes 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. Has the responsibility to lead audits as well as serve as the primary quality representative for CBRE operations during external agency or client audits.

Responsible for the vendor management program for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE regulated vendor qualification process (as well as any client directed qualification program).

Oversees the execution of the training and qualification program for CBRE employees. Ensures that all employees are qualified for the role they perform.

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 CBRE 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.

Performs other duties as assigned.


SUPERVISORY RESPONSIBILITIES  

Provides formal supervision to individual employees within single functional or operational area. Recommends staff recruitment, selection, promotion, advancement, corrective action and termination. 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. Leads by example and models behaviors that are consistent with the company's values.

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. 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.

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 training and qualification programs preferred.

Experience and knowledge of Quality and Compliance Systems within Life Science Environment(s) a plus.

Quality auditing experience a plus.


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