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Quality & Compliance Manager - onsite

Job ID

151569

Posted

24-Jan-2024

Service line

GWS Segment

Role type

Full-time

Areas of Interest

Facilities Management, Risk Management

Location(s)

Charlotte - North Carolina - United States of America, Concord - North Carolina - United States of America, Huntersville - North Carolina - United States of America, Kannapolis - North Carolina - United States of America

ABOUT THE ROLE

As the Quality & Compliance Manager, your primary responsibility is to oversee and ensure all operations align with both internal and external protocols and regulations. You are the guardian of quality, ensuring that all outputs meet the highest standards. Your role involves managing any non-compliance issues, mitigating risks, and driving continuous improvement in the organization. You're a vital part of the team, promoting adherence to quality and regulatory standards, thereby enhancing overall efficiency and performance.

WHAT YOU’LL DO

This role involves overseeing daily Quality and Compliance activities at one or more sites, assessing adherence to both local and global regulations, and ensuring client-specific requirements are met.

Delivers and implements the 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.

Interfaces and partners with functional areas and leadership teams. Communicates initiatives and issues to appropriate teams and management.

Manages inspection readiness program. Leads and serves as quality representative for internal and external audits. Accountable for audit observations and the associated corrective measures.

Oversees vendor management program. Ensures all GxP service providers are qualified per the regulated vendor qualification process.

Responsible for the training and qualification program. Trains on the use of elements within the Quality Management System.

Drafts, negotiates and continuous oversight of terms of Quality Agreements with clients and vendors. Ensures the QA staff is delivering on the objectives.

Oversees the execution and monitors the success of CBRE's quality of service initiatives for non-regulated services.

Manages the triage, assessment, and OpEx portions of an observation/deviation when required. Assist with providing quality overview of all deviations. Partner with client regarding content, root cause conclusions, CAPA and efficiency checks.

Track and report monthly quality metrics to client leadership.

Manage quality projects to bring CBRE into compliance with FDA and client standards.

Leverage CBRE corporate & client quality contacts to develop advanced methodologies.

Performs other duties as assigned.

Supervisory Responsibilities

May 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

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.

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

Education and Experience

Bachelor’s degree in biology, microbiology, chemistry, or engineering; or a minimum 5+ years related work experience required. Previous experience within a quality organization within Life Science Environment(s) preferred. Niche training in quality assurance audits preferred. Previous supervisory experience a plus.

Certificates and 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. 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 in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.

Other Skills & 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 preferred. Previous oversight of compliance and or programs within a regulated environment preferred.

GMP and quality auditing experience required.

Scope of Responsibilities

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.

Equal Employment Opportunity: CBRE is an equal opportunity employer that values diversity. We have a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.

Candidate Accommodations: CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company’s success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at recruitingaccomodations@cbre.com or via telephone at +1 866 225 3099 (U.S.) and +1 866 388 4346 (Canada).

NOTE: Some, but not all, of our positions may have an additional requirement to comply with COVID-19 health and safety protocols, including COVID-19 vaccination proof and/or rigorous testing. If you have questions about the requirement(s) for this position, please inform your Recruiter.

CBRE GWS

CBRE Global Workplace Solutions (GWS) works with clients to make real estate a meaningful contributor to organizational productivity and performance. Our account management model is at the heart of our client-centric approach to delivering integrated real estate solutions. Each client is entrusted with a dedicated leader and is supported by regional and global resources, leveraging the industry's most robust platform. CBRE GWS delivers consistent, measurably superior outcomes for our clients at every stage of the lifecycle, and across industries and geographies.

Find out more (https://www.cbre.com/real-estate-services/directory/global-workplace-solutions)

CBRE, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)