Quality & Regulatory Affairs Manager in Newquay, United Kingdom at Pall

Date Posted: 7/18/2019

Job Snapshot

Job Description

Job ID: LIF004134

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 https://www.pall.com/en/about-pall.html.


Description

We are currently seeking a Quality & Regulatory Affairs Manager to support our growing business.

Position Objective: 

This is an exciting opportunity to work for a large, dynamic and faced paced global organisation. Due to an internal promotion, an opportunity has now become available for a Quality & Regulatory Affairs Manager to join our team in Newquay. The successful candidate will be responsible for managing a team of 5 direct reports as well as being the lead for all Quality Assurance & Regulatory Affairs functions for the site. They will also implement and maintain QMS site compliance in accordance to the business unit’s specific requirements. If you are looking for a fast-paced challenging Quality Assurance & Regulatory Affairs role then this is the role for you.

Role and Duties:

  • Provide leadership and technical expertise to site & Business Unit in the implementation of relevant Quality Systems, improvements and production requirements. This includes licensing partners as well as suppliers.
  • Maintain QMS to ISO 9001, ISO 13485, FDA 21 CFR Part 820 and other standards in accordance with BU specific requirements, including document control and record retention.
  • Data analysis and implementation of continuous improvement plans to meet agreed KPI's
  • Implement BU-specific regulatory requirements and changes, including labelling requirements, and certifications for non-branded products (OEM).
  • Implement field action risk assessment (FARA) actions as directed by Corporate Medical.
  • Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes.
  • Validate plant level change control, including PDR or IPCO, OQ, PQ requirements as applicable to the product.
  • Implement and maintain specified audit plan based, management of associated corrective actions. Including a Supplier Audit program.
  • Responsible for Risk Management acc. to ISO 14971 at site level
  • Manage plant customer complaint CAPA and adhere to corporate escalation and reporting guidelines
  • Facilitate customer visits and audits.
  • Responsible for Customer Quality Agreement and Questionnaire completion (anything related to Medical BU including products manufactured at other Pall sites sold by Medical)
  • Provide QARA support where requested to OEM customers and branded products
  • Prepare and rollout plant-specific training; provide corporate QARA training to plant associates
  • Develop talent within the QA function, undertake rigorous approach to P4G and D4G.
  • Manage site specific QARA organization to meet BU and site goals, clearly defined roles and responsibilities; and develop talent.
  • Responsible for product batch release at the site.
  • Responsible for Product Environmental Compliance (PEC)

Job Requirements



Qualifications

Basic Qualifications/ Experience: 

  • Degree qualified in a Quality, Engineering or relevant discipline.
  • Demonstrated ability in a senior manager role within a Medical or Pharmaceutical company, with people management responsibility.
  • Proven experience in Quality Management and Medical Devices preferably within an international FMCG environment.
  • Proven track record of delivering Quality change with experience of World Class Quality techniques.
  • Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO9001, FDA 21 CFR Part 820, and ISO 13485
  • Ability to think and operate strategically
  • Excellent interpersonal and communications skills required; experience working in a matrix environment and managing multiple priorities and projects with dynamic timelines to execution.
  • Focused and results oriented with a change management and growth mindset.
  • Experience working in a highly technical manufacturing organization, requiring a comprehensive understanding of complex concepts and principles.
  • ISO Standards; US Code of Federal Regulation (CFR), GMP and Industry Specific Regulatory knowledge; Industry specific application knowledge; Data analytics Expertise, including statistical practitioner; Strong Mfg. experience; Leadership skills; Strong communication skills; Success in a global, matrixed organization; Cross functional Quality culture leader

Interested? Join the PALL Team!

If you would like to explore this exciting opportunity further and find out more about our competitive salary package, please do not hesitate to contact us!




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.