QUALITY & COMPLIANCE DIR

Quality & Compliance Dir

Job ID

189817

Posted

25-Oct-2024

Service line

GWS Segment

Role type

Full-time

Areas of Interest

Consulting, Facilities Management, Health and Safety/Environment

Location(s)

El Cajon - California - United States of America, Juncos - Puerto Rico - United States of America, Morrisville - North Carolina - United States of America, Remote - US - Remote - US - United States of America

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 morecovering 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 large scoped client accounts (may include multiple accounts/clients). Alternatively, this role may lead corporate CBRE (not assigned to any account) QA departments facilitating the company QA and Compliance objectives and how those objectives are cascaded to client accounts. This role manages the staff that is responsible for the creation, implementation, and routine maintenance, of CBRE and/or the client's Quality Management System(QMS). This role is responsible for the delivery of all quality and compliance deliverables for regulated and non-regulated services provided to the client; per the master service agreement, Quality agreement, and any local service level agreements.

*This role is remote supporting continental USA*

+ Responsible for all contractual agreement aspects (MSA, QA, SLA) where regulated GxP quality and/or quality of service provided is stipulated. Ensures that CBRE is appropriately staffed to achieve the quality deliverables committed in those contracts.

+ Evaluates, selects, implements, and actualizes best practices across the client portfolio. Researches, creates, and aligns quality initiatives with current regulatory bodies requirements as a function of the scope of work CBRE provides the client.

+ Oversees the staff responsible for the CBRE quality & 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' 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.

+ Oversees the staff responsible for the inspection readiness program for the site. Depending on staffing strategy, may have responsibility to lead audits as well as serve as the primary quality representative for CBRE operations during external agency or client audits. Is accountable to the client and/or agency for audit observations and the associated corrective measures.

+ Oversees the staff responsible for the vendor management program for the site. Ensures GxP compliance and qualification of all regulated service vendors.

+ Manages the staff(s) assigned to the Quality & Compliance Department (may involve multiple client accounts and staffs).

+ Author and negotiate terms of Quality Agreements with clients and vendors.

+ Oversee 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.

*Supervisory responsibilities*

Manages the planning, organization, and controls for the Quality & Compliance group(s). Will be responsible for a mix of direct and matrix reports. 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. Monitors appropriate staffing levels and reports on utilization and deployment of human resources. Leads and supports staff in areas of staffing, selection, training, development, coaching, mentoring, measuring, appraising and rewarding performance and retention. Leads by example and models behaviors that are consistent with the company's values

*What Youll Need:*

*EDUCATION and EXPERIENCE*

Bachelor's degree in Biology, Microbiology, Chemistry, or Engineering; or equivalent related work experience. Minimum of 8-10 years experience in a pharmaceutical research/manufacturing quality organization. Previous departmental experience required.

*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.

*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.

Formal training with lean manufacturing, Six Sigma, 5S programs (among others) preferred.

Previous oversight of training and qualification programs within a regulated environment preferred.

Well versed with Quality and Compliance management systems within Life Science Environment(s).

Quality auditing experience preferred.