Global Biotechnology Complaint Manager in Portsmouth, United Kingdom at Pall

Date Posted: 8/6/2019

Job Snapshot

Job Description

Job ID: PAL003060

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


Position Objective: 

• Identify and coordinate cross-functional activities to ensure regulatory and Pall Corporate compliance of global BU Complaint Handling and CAPA requirements.
• Meet objectives, goals and timeline requirements communicated by BU customer, regulatory certification and Corporate
• Assure customer satisfaction through timely response of investigation findings and proposed actions.

Role and Duties:

1. Interpret Complaint Handling regulations for BU execution and enforce required modifications of operational procedures to ensure continued compliance. 

2. Responsible for managing the BU Complaint Handling processes, including analytics, to assure compliance to Corporate workflow and timelines 
a. Monitor BU global complaints for the detection of potential non-compliant trends
b. Identify and escalate potential critical trends
c. Support the preparation of reports and analytical tools that are used for internal decision making
d. Review customer responses to assure appropriate actions are taken 
e. Monitor BU complaints for post CAPA failures and escalate
f. Monitor BU complaint aging and drive the process to completion including escalation when necessary 

3. Interact with key customers regarding BU investigation of post market reports of quality concerns and Pall actions.
a. Attend key customer meetings
b. Present quality trends and review investigation findings and proposed actions 
c. Evaluate customer metrics and implement process changes for improved customer satisfaction. 
4. Deploy CAPA process consistently across the BU
a. Monitor BU/Site CAPA workflow from creation to closure
b. Support site in CAPA review board to assure consistency of BU CAPA assignment
c. Drive culture from CA to PA
d. Monitor and report on BU CAPA KPI results

Job Requirements


• Strong knowledge of ISO9001 requirements.
• Technical knowledge of supported product lines.
• Come from a cGMP background with an intimate working of the healthcare market (pharmaceutical, biotechnology and / or medical devices)
• Excellent writing skills.
• Ability to effectively prioritize and manage multiple project workloads.
• Experience with SAP, Pilgrim, trending and analysis reporting.

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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.