|at ( view profile)|
|Date Posted||December 18, 2019|
Contract GMP Manufacturing
|Address||3230 Deming Way|
Group Leader- GMP Laboratory # 161372
Provides management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. Plans and monitors the progress and quality of projects by utilizing the financial and quality management tools available at PPD.
• Prepares, reviews and approves study protocols, project status reports, final study reports and other project-related technical documents.
• Designs experimental study and participates in technical troubleshooting.
• Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigations, deviations, and QA facility and data audits. Leads client and FDA audits.
• Allocates, schedules and manages laboratory resources for group's project activities and updates project status. Reviews timesheet reports for billing accuracy.
• Responds to clients questions and needs; leads client technical meetings.
• Assists in preparation of proposals by provided project definition.
• Identifies new opportunities within client base and ability to work with business development to pursue opportunities.
• Coordinates and prioritizes project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.).
• Assists management in their responsibilities.
• Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.
Education and Experience:
• Bachelors degree
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.
• 1+ year of leadership responsibility
Knowledge, Skills and Abilities:
• Proven leadership skills
• Ability to cultivate a collaborative work environment with a team
• Effective negotiating skills
• Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
• Ability to troubleshoot multiple systems/methodologies
• Ability to independently optimize analytical methods
• Understanding of basic financial terms and definitions as it applies to the business
• Understanding of proposal and project scope as it relates to pricing, resource management and the impact on business
• Project and time management skills
• Effective written and oral communication skills as well as presentation skills
• Ability to train and mentor junior staff
Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
Working Conditions and Environment:
• Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
• Occasionally drives to site or client locations, occasionally travels within the United States.
• Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.