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Project Manager - Labs (Metrology)
Middleton, WI
Job Description
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health. Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.Summarized Purpose: Monitors all aspects of designated projects in GMP Labs and is accountable for overall project performance and client's satisfaction by meeting their needs and expectations. Provides internal consulting on lab support issues and identifies opportunities for efficiency improvement. Responsible for managing the lifecycle of equipment including purchase, support and retirement. Responsible for managing Support Service vendors, contracts and purchase orders.Essential Functions: Provides oversight and coordination of designated projects. Reviews, interprets and translates user requirements completely and accurately. Communicates with internal departments and external vendors to ensure project requirements are understood, agreed and followed up at all times. Facilitated flow of technical information and project status to all stakeholders. Consults and utilizes, where appropriate, the technical input from support and laboratory staff to assist with the management of projects.Prepares and maintains procurement documentation and follows budgets and contracts. Maintains at all times and updated project master file with version controls on equipment specifications, requirements, budget and status. Ensures sponsors have authorized sign off on procurement and related documents as needed.Coordinates change control and qualification documents and processes for new and existing assets. Collaborates with support management to assure resources are assigned and aligned with project timelines. Assures compliance with FDA and GMP guidelines, PPD SOP's, personnel policies and procedures, and other regulations as applicable.Actively consults with IT and data management development groups in the design, validation and implementation of new software and functionalities pertinent to project management and asset lifecycle activities.Develops and maintains metrics and KPIs to measure support service performance. Guides and supports workflow of other project managers with special attention to training of junior personnel. Performs as a mentor and trainer for (newly assigned) project managers, identifies areas for development and efficiencies in performing tasks. Authors, reviews, revises, and implements relative procedural documents.Qualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience.Knowledge, Skills and Abilities: Experience with validation requirements in a GMP environment. IQ, OQ, PQ. Change Management and Risk Assessment. Experience leading small to medium sized projects (<$1MM in budget) Experience with electronic project management tools, such as Microsoft Project or Microsoft Planner Knowledge of Lean concepts such as Process Flow Diagrams, Key Performance Indicators, DMAIC process Demonstrated ability to coordinate work with various functions that are not in the department reporting structure Ability to effectively communicate across, up and down the organization Working Environment:PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner Able to work upright and stationary and/or standing for typical working hours Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments Able to use and learn standard office equipment and technology with proficiency May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments Able to perform successfully under pressure while prioritizing and handling multiple projects or activitiesPPD Defining Principles:- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD -If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.
Job Summary
Company
Pharmaceutical Product Development, Inc.
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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