Quality & Compliance Manager - Pharmaceutical Facility Sites
CBRE
Quality & Compliance Manager - Pharmaceutical Facility Sites
Job ID
206624
Posted
14-Feb-2025
Service line
GWS Segment
Role type
Full-time
Areas of Interest
Workplace Strategy
Location(s)
Irvine - California - United States of America
CBRE Global Workplace Solutions (GWS) works with clients to make real estate a significant 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, demonstrating 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.
**About the role**
As a Quality and Compliance Manager, your primary responsibility is to oversee and ensure all operations align with both internal protocols and external regulations. You are the guardian of quality, ensuring that all outputs meet the highest standards. Your role involves leading 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 being responsible for 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.
+ Runs 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.
+ Leads 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.
**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 preferred; or a minimum 5+ years related work experience required. Previous experience within a quality organization within Life Science Environment(s) preferred.
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.
**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 preferred. Previous oversight of compliance and or programs within a regulated environment preferred.
GMP and quality auditing experience required.
**Why CBRE?**
With 115,000 employees globally, creating a culture of workplace safety and wellbeing is central to our commitment to our people.
Comprehensive training will advance every stage of your professional career at CBRE, from day one to retirement. You'll never stop learning. And never stop progressing. There are literally no limits as to how high you can go. CBRE is committed to an inclusive environment that provides everyone with the opportunity to achieve.
+ Our competitive and comprehensive benefits program was designed to make sure our employees feel valued in their roles, with benefits that support the mental, physical, emotional, and financial health of you and your family!
+ **California Residents:** CBRE carefully considers multiple factors to determine compensation, including a candidate’s education, training, and experience. The minimum salary for the Quality and Compliance Manager is $145,000 annually and the maximum is $162,300 annually. The compensation that is offered to a successful candidate will depend on the candidate’s skills, qualifications, and experience. Successful candidates will also be eligible for a discretionary bonus based on CBRE’s applicable benefit program. This role will provide the following benefits: 401(K), Dental insurance, Health insurance, Life insurance, and Vision insurance.
**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 recruitingaccommodations@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, Inc. is an Equal Opportunity and Affirmative Action Employer (Women/Minorities/Persons with Disabilities/US Veterans)
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