Quality Systems Manager (Biostatistics)

This position provides consulting and mentoring to all levels of staff on quality principles as they relate to any Biostatistics processes at their assigned location. Specifically, the Quality Systems Manager takes a leadership role with the Local Management Team personnel at assigned location to define problems, problem solution strategies, and develop implementation plans for quality improvement. Develops or coordinates strategic initiatives, which may include the management of junior Quality Systems staff. Also, works with Senior Management to establish overall quality and performance metrics, collect and analyze metrics data, and present results to peers and senior management. Serves as the coordinator for the development and delivery of training initiatives regarding process compliance and quality improvement.

PRIMARY ACCOUNTABILITIES:

.Collaboration with Quality Systems Managers from other locations
.Meet weekly with Quality Systems Managers from other locations to develop and maintain a common agenda for quality management across locations
.Meet monthly (initially biweekly) with the Vice President of Biostatistics to review progress on major quality initiatives, training, CAPA reporting, and metrics reporting


TRAINING MANAGEMENT:
.Develop and implement training material in basic quality science combined with specific PPD Biostatistics quality procedures Coordinate training in use of Quality Toolkit
.Participate in on-going development and deployment of Biostatistics Foundation Course curriculum
.Coordinate resourcing and delivery of training for SOPs and Guidances, as these documents are launched or revised
.Assure that all local staff complete required training on time
.Assist local managers with assessing specific local training (and retraining) needs, both at the group level and individual level
.Worksystem monitoring, assessment, and formulation of ideas for tuning
.Serve as the local quality auditor, sufficient to have a general understanding of trends and risks across projects within assigned location
.Periodically share this information with the other Quality Systems Managers
.Complete one complete quality audit per quarter for a specific major deliverable
.Develop and add quality tasks/responsibilities to all job descriptions and performance evaluation checklists, in collaboration with other Biostatistics Quality Systems Managers
.Participate in development and maintenance revisions to SOPs and Guidances
.Metrics and CAPA collection and reporting
.Administer CAPA and Deliverables tracking programs
.Assure that all CAPA events are reported through the CAPA system on a timely basis
.Assure that all CAPA follow-ups are completed in a timely manner
.Assure that local metrics collection and reporting remains timely and accurate
.Refine the metrics reporting in collaboration with other Biostatistics Quality Systems Managers
.Work collaboratively within the local management team.
.Participate in weekly local management team meetings, representing the quality management perspective
.Assure that quality principles are being practiced consistently within the location
.Serve as a quality mentor to local project teams
.Assist managers in evaluating staff on quality performance




EDUCATION AND EXPERIENCE:

.BA/BS degree or equivalent in computer science, statistics, biostatistics, mathematics or related field
.Five years of statistics, programming, clinical trial research, and/or quality principles experience.
.At least one year supervisory experience (Required)
.Or equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job
.SAS skills at the level of PPD Programmer Analyst
.Curriculum development, deployment, and teaching skills
.CAPA and Root Cause Analysis training
.One or more ASQ certifications recommended, especially Certified Quality Manager
.Detailed working knowledge of current PPD Biostatistics worksystem, particularly quality review activities

KNOWLEDGE, SKILLS AND ABILITIES:

.Work efficiently and effectively with minimal direct supervision
.Ability to periodically assess departmental policies and procedures and propose changes that yield the best quality improvement return for the time and effort invested
.Ability to analyze/interpret data and be able to use independent judgment in conducting project audits, and recommending an appropriate course of action where findings indicate a need
.Demonstrate technical skills and logic/problem solving capability
.Experience demonstrating a strong attention to detail
.Knowledge of clinical trials research
.Ability to train and mentor others in continuous process improvements
.Ability to motivate and inspire staff to think and act for quality improvement
.Demonstrate leadership, initiative, and motivation
.Demonstrate positive attitude, enthusiasm toward work, and the ability to work well with others
.Ability to work well within a multi-disciplinary team
.Ability to facilitate communications with clients, project teams, departments, and staff
.Excellent written and verbal communications skills
.Ability to independently and effectively organize and manage multiple assignments with challenging timelines
.Ability to adapt and adjust to changing priorities

PPD is an Equal Opportunity Employer


Additional Information
Position Type:Full-Time Employee

Ref Code:11993


Contact Information