Controls Director

CBRE; Dallas (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

CBRE seeks a senior leader to guide the Quality Representatives staff on major client accounts or CBRE's corporate QA teams. You will ensure delivery of all quality and compliance deliverables under MSA, QA, and SLA agreements, coordinating with client leadership and internal teams.

Applicants should bring 8–10 years in pharma QA, GxP expertise, and a track record in audits, vendor management, and quality systems.

Qualifications

• Bachelor's degree in a life sciences or engineering field; 8–10 years in pharma QA
• Experience leading QA/compliance teams and audits in regulated environments
• Strong knowledge of GxP, FDA/ISO audits, and quality systems

Responsibilities

• Lead CBRE Quality Representatives staff on large client accounts or oversee corporate QA departments.
• Ensure delivery of quality/compliance deliverables per contracts, MOAs, and SLAs.
• Oversee QA/compliance programs and coordination with client leadership to communicate issues and improvements.
• Author and negotiate Quality Agreements with clients/vendors.
• Manage vendor qualification and inspection readiness programs; lead audits as needed.

Skills

Leadership

GxP Quality

Regulatory Compliance

Quality Management Systems

Audits

Vendor Management

Communication

Education

Bachelor's degree in Biology/Manufacturing/Engineering

Tools

SAP

Trackwise

Regulus

CMMS

Job description

Responsibilities

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.

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. Ensures that CBRE is appropriately staffed to achieve the quality deliverables committed in those contracts.

Responsibilities

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.

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. 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.
• Performs other duties as assigned.

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.

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 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.
• 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 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.

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.

SAFETY

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 [e-mail] or via telephone at [phone] (U.S.) and [phone] (Canada).