Quality​/Compliance Manager

Quality/Compliance Manager Skip to main content#Quality/Compliance Manager page is loaded## Quality/Compliance Manager Apply remote type:
On-site locations:
Rocky Mount, NCtime type:
Full time posted on:
Posted Todayjob requisition :
REQ
519374
** JLL empowers you to shape a brighter way**.Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.  Whether you’ve got deep experience in commercial real estate, skilled trades or technology, or you’re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward.##

** Quality Manager**## The
** Quality/Compliance Manager
** must have a strong background in quality assurance requirements for a Biotech/Pharmaceutical Manufacturing facility from an operations, facilities, and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities team, and its subcontractors perform the work in full accordance with contractual, procedural and regulatory requirements within a cGMP culture environment. This Manager must have a solid understanding of cGMPs as they relate to the performance of maintenance and repairs of equipment, facilities and utilities.

An Engineering background, or equivalent experience in lieu of, would be desired. The position requires the ability to prepare and manage documents, investigations, CAPAs, audits, change control documentation, and training materials for use by the facilities team in the performance of their  addition, this position is expected to interface with the site’s quality unit to ensure that through the established Quality Agreement all applicable regulations and procedures are followed, and that the work performed by the team is documented and recorded in the proper fashion.

It is responsible for sustaining a Quality program and culture at a state-of-the-art cGMP manufacturing facility. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.  A background and understanding of FDA regulations including 210 CFR part 210 and 211 would be desired but not required.

The Quality/Compliance Manager must have a strong commitment to quality assurance, and a willingness to help develop a quality first culture on the Site. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. The person must have good oral and written communication skills including the ability communicate and gain the trust of all levels of management and interface with a diverse customer base including technical and non-technical personnel.
** Responsibilities*** + Perform investigations of significant event deviations along with the corresponding root cause analysis (RCA), impact assessment and trend evaluations.  + Lead assigned Corrective and Preventive Actions (CAPA)  + Developments and reviews of trend analysis reports related to the facility scope of work.  + Management of the GxP Contractors compliance program (e.g. qualification, agreements, audits, performances, etc.).  + Oversee the quality/compliance program as it relates to facility support systems including maintenance of equipment, environmental monitoring systems, HVAC, utilities, and site support services such as calibration, janitorial cleaning, pest control, garments, and shipping/receiving activities.  

+ Manage the site’s self-assessment program along with the corrective actions as a result of.  + Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements.  + Reads and understands the applicable Service Level Agreements, standard operating procedures helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys.  

+ Support and oversee the team’s…