Regulatory Dossier Project Manager in Portsmouth, United Kingdom at Pall

Date Posted: 8/9/2018

Job Snapshot

Job Description

Job ID: SUT000369

About Us

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.



Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.



Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.



Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.



To learn more about Pall, please visit www.pall.com/green.



Description

This position is a key member of the Pall Biotech Technical Documentation & Regulatory Strategy team . The Regulatory Dossier Project Manager  will be responsible to track the execution of the Regulatory Dossier programme. He/She will report functionally to the Vice President Technical Documentation & Regulatory Strategy.  The position will require daily interaction our Scientific & Service Laboratory team, the R&D team, the product engineering team, the quality team and the IT team to ensure proper execution of the project.

The main responsibility will be to ensure execution of the Regulatory Dossier Project according to specification, within budget and on time. 
  • Development of the resource plans with the key stakeholders;
  • Monitor the quality of the deliverables;
  • Track and present the KPI according to request;
  • Help to set-up the meetings (Kaizen events...) with the use of the appropriate business tools;
  • Monitor the budget;
  • Facilitate the work of the cross -functional teams.

Job Requirements



Qualifications

QUALIFICATIONS: 

EDUCATION: 
  • At minimum a BS degree in Life Sciences Engineering (Biotech, Biology or Chemistry), a qualification in QA and / or validation would be a plus. 
EXPERIENCE & KNOWLEDGE
  • 5 + years of experience in project management in the Biotech industry either as an end -user or as a supplier.
  • Ability to communicate clear messages. 
    • Excellent interpersonal and communications skills required including cultural differences awareness; 
    • Experience in working in a matrix environment; 
    • Excellent writing and communication skills;
    • Fluent in English: both in writing and spoken: 
    • Focused and results oriented;
    • Proven track records of successfully navigating a matrix organisation;
    • Sensitivity to regulatory, quality and documentation aspects within the Biotech industry;
  • Experience of working in a highly technical organisation interacting with scientists, engineers, quality and business people. 
  • Ability to prioritize tasks and drive for results.
  • Seasoned experience using Microsoft PowerPoint, Word; Excel and Microsoft project. 
  • Up to 40% travel, including domestic and international travel to factories, technical and business centers. 


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.