25 days old

Quality & Compliance Manager- Life Sciences

Indianapolis, IN 46204
JOB SUMMARY
The purpose of this position is to lead the CBRE Quality functions on medium to large scoped client accounts (may include multiple accounts/clients). This role manages the creation, , improvement, 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. This position liaises between the client's Quality Assurance team leadership and CBRE Operations to identify and drive improvement opportunities in operations and the QMS and to support routine quality assurance and control deliverables.  This position supports change, event & root cause analysis processes through creation, 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
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.
 
Responsible for driving Continuous Improvement (CI) of operations and processes (CBRE & Client).  Responsible for the optimization of the account Quality Management System.  Actively reviews operational data and processes to identify improvement opportunities.  Works closely with Operations staff and client teams  to identify, develop business case, design, develop and test efficiency improvement initiatives.  Develops and executes CI plans. Leads improvement initiatives from concept through execution and verification of performance.
 
With the support of the Account Team, 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 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 the client during review meetings. Appropriately escalates and notifies CBRE and client management of quality and compliance issues.
 
Responsible for the inspection readiness 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.  Accountable to the client and/or agency for audit observations and the associated corrective measures.

Responsible for design and implementation of oversight program for GxP Service Providers. 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). Accountable for development, execution of 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 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.
 
Oversees the execution and tracks the success of CBRE quality of service initiatives on the account for non-regulated services.
 
Development and execution of  Quality Agreements with clients.
Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in creation and management of changes, provides solution options and assists in execution of corrective/preventive actions.
 
Monitors critical KPIs related to quality of delivery and service, and works with Operations to perform root cause analysis, and develop and implement solutions to improve performance
 
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.
 

 

Requirements

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 with continuous improvement focus required. Previous experience within a quality organization within Life Science Environment(s) preferred. Specialized training in quality assurance audits preferred.  Previous Quality Engineering and Supervisory experience a plus.
 
CERTIFICATES and/or LICENSES
FDA, ISO, ASQ or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law. Green Belt or Black Belt Six Sigma Certification preferred but not required.

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 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/or 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). 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.

Categories

Posted: 2019-10-18 Expires: 2019-11-18

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Quality & Compliance Manager- Life Sciences

CBRE
Indianapolis, IN 46204

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