Quality & Compliance Manager- Pharmaceutical Manufacturing

About the role

The purpose of this position is to lead the CBRE Quality Representatives staff on a large prioritized client account. This role leads the creation, revision, and enforcement of all aspects of the CBRE Quality Management System (QMS), or in situations where CBRE operates within the client's QMS, ensures the integration and ongoing oversight aspects required by that QMS are appropriately performed by the CBRE Quality Representatives.

This position collaborates with the client's Quality Assurance team leadership to support routine quality assurance and quality results. This position supports change, event & root cause analysis processes through review and/or approval actions. This role ensures all CBRE employees are qualified for the work they are performing.

Lastly, this position is responsible for ensuring all master service agreement and quality agreement deliverables are implemented per those respective contract terms.

This role is fully onsite in Lebanon, IN.

• Leads the day-to-day Quality and Compliance Team operations at one or more account sites. Monitors operations at each site and resolves compliance status with regards to local and global regulatory standards as well as client specific requirements as defined in the master service agreement or Quality Agreement.
• Delivers and implements the CBRE 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 functional areas and 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 raises and notifies CBRE and client management of quality and compliance issues.
• Responsible for the inspection readiness program for the site. Inspection readiness may include periodic CBRE self inspection, client self inspections, or any external agency inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality representative for CBRE operations during external agency or client audits. Accountable to the client and/or agency for audit observations and the associated corrective measures.
• Responsible for the vendor management program for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE regulated vendor qualification process (as well as any client directed qualification program). Accountable for approving all necessary quality agreements with third party service providers and ensuring the ongoing oversight of those vendors is performed.
• Responsible for the training and qualification program for CBRE employees. Ensures that all employees are qualified for the role they perform.
• Trains CBRE account personnel on the use of elements within the Quality Management System. Ensures the QA staff is qualified and delivering on the objectives of the QMS, annual quality plan, and the quality agreement with the client.
• Oversees the execution (maybe required to participate) and tracks the success of CBRE quality of service initiatives on the account for non-regulated services.
• Authors and negotiates terms of Quality Agreements with clients and vendors.
• Coordinates 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.