Regional Quality & Compliance Director

Responsibilities

The purpose of this position is to lead the CBRE Quality Representatives staff on large scoped client accounts (may include multiple accounts/clients) or lead corporate CBRE QA departments facilitating company QA and compliance objectives and how those objectives are cascaded to client accounts. This role manages the staff responsible for creation, implementation, and routine maintenance of the CBRE and/or client Quality Management System (QMS), and the delivery of all quality and compliance deliverables for regulated and non‑regulated services per MSA, Quality Agreement, and local service level agreements.

Essential Duties and Responsibilities

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

Evaluate, select, implement, and actualize best practices across the client portfolio. Research, create, and align quality initiatives with current regulatory body requirements as a function of scope of work CBRE provides to clients.

Oversee staff responsible for CBRE quality & compliance program and/or client compliance program. Attend Quality Forum monthly meetings, provide in‑depth explanations for monthly reports and metrics, lead and participate in continuous improvement for CBRE and the client.

Interface, partner and interact with CBRE and client leadership teams, communicate quality and compliance initiatives/issues, report compliance status, appropriately elevate issues to management.

Oversee staff responsible for inspection readiness program. May lead audits and serve as primary quality representative for CBRE operations during external audits. Accountable for audit observations and corrective measures.

Oversee staff for vendor management program, ensuring GxP compliance and qualification of all regulated service vendors.

Manage staff assigned to Quality & Compliance Department (multiple client accounts). Author and negotiate terms of Quality Agreements with clients and vendors. Oversee vendor management program and qualify GxP vendors.

Investigate deviations, issues, and manage Corrective/Preventive Actions. Participate in creation and management of changes. Perform other duties as assigned.

Supervisory Responsibilities

Manage planning, organization, and controls for Quality & Compliance group(s). Responsible for mix of direct and matrix reports. Approve staff recruitment, selection, promotion, corrective action, and termination. Monitor staffing levels, report utilization and deployment. Lead and support staff in training, development, coaching, mentoring, performance appraisal and retention. Model company values.

Qualifications

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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 and 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 complex business documents; respond effectively to sensitive issues; write reports and presentations; motivate and negotiate with key stakeholders; engage new people; demonstrate a warm and engaging demeanor.

Financial Knowledge

Requires in‑depth knowledge of financial terms and principles, ability to calculate complex figures, forecast and prepare budgets, and conduct financial/business analysis including report preparation.

Reasoning Ability

Ability to solve advanced problems and deal with complex situations, possessing expert level analytical and quantitative skills, developing strategic solutions, and making recommendations that directly affect the company.

Other Skills and Abilities

Experience with desktop publishing, Microsoft Office Suite, Online Help, SAP, Trackwise, Regulus, and CMMS systems. Formal training in lean manufacturing, Six Sigma, 5S programs preferred. Previous oversight of training and qualification programs within a regulated environment preferred. Well versed with Quality and Compliance management systems within Life Science environments. 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.