Manager, Quality

 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

This position is responsible for the day to day management and effective application of all the Quality Assurance and Quality Control functions at the Hattiesburg, Mississippi location.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Provide oversight of Quality Assurance and Quality Control operations including Deviation, CAPA, Document Control, Product Testing, Batch Record Review, Product Release, and Change Control. 
•    Collaborate with the Management Representative to ensure the product is managed within the regulations for change control, deviations, etc. as applicable.
•    Support Medical Device Regulation (MDR) certification
•    Maintain a document control system for Quality System documents and associated documents used and generated on the site that are compliant with regulations to support business operations.
•    Ensure Emergent documentation retention requirements are applied to GXP documents.
•    Provide oversight for training personnel and management of training processes and content.
•    Represent Quality Assurance and Emergent during regulatory and ISO inspections.
•    Represent Quality Assurance and Emergent for customer relation activities.
•    Review contract negotiations for potential customers (specific to review of sections pertaining to product disposition and customer shipment dispositions), as needed.  
•    Quality Assurance approver in reviewing various compliance documentation such as deviations, CAPAs, audits, change controls, validation & technical study protocols and other cGXP compliant documentation.
•    Complete FDA inspection response reports, monthly response updates and coordinated response and gap analysis teams, as needed.
•    Provide Quality oversight and final disposition of product for distribution.
•    Provide Quality oversight and final disposition of shipment dispositions.
•    Development, management and maintenance of quality systems.
•    Provide Quality oversight of product inquiry and product complaint system.
•    Define quality metrics relevant for Management Review.
•    Prepare trend reports and summaries for routine Quality Management Review.
•    Communicate metrics, trends, and data summaries to senior management as part of Management Review, using a variety of media: intranet, reports, and presentations
•    Maintain metrics within predetermined limits.
•    Align site with Global processes.
•    Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements.
•    Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
•    Interact with contract, corporate, ISO and governmental agency auditors.
•    Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group.
•    Plan and track all budgetary requirements.  Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel.
•    Provide routine reports regarding budgetary updates and variances against approved budgets.
•    Responsible for identifying defects and have the authority to report device defects at any time. 
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor Degree in Biological Science or similar science.
•    Minimum of 8 years of Medical Device (ISO 13485:2016 and 21CFR 820s) Quality experience with increasing responsibilities. 
•    Previous experience in management of quality systems and Quality department. Highly desirable to have minimum of 5 years of supervision experience. 
•    Previous experience working with FDA  and participating in regulatory agency inspections.
•    Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
•    Must have personnel management skills.
•    Highly desirable to have prior expe