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Vice President of Quality and Regulatory Affairs in Givisiez, Switzerland at Pall

Date Posted: 5/9/2019

Job Snapshot

Job Description

Job ID: LIF004159

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

The Role:
The Vice President of Quality and Regulatory Affairs is responsible for best-in-class practices and consistency globally to improve and sustain levels of quality, compliance and regulatory affairs across Pall’s Biotechnology Business Unit.  Reporting to the General Manager for the Business Unit, this position provides leadership to the Business Unit’s Quality and Regulatory Affairs organization, ensuring accountability for the performance and results of the business. Promoting a company-wide culture of quality excellence and an understanding of the key elements related to quality systems, this role partners with Operation leaders to foster a culture that focus on both quality and on-time-delivery.

Key Responsibilities:
  • Accountable for the performance and results related to the roles and responsibilities of the quality and regulatory affairs organizations, including: compliance, registrations, labeling, relationships with regulators and customers, talent management, organizational development and effective communications across Pall’s Biotechnology Business Unit.
  • Collaborates with Corporate QARA, R&D, Product Engineering, Sales and Operations to develop quality targets for new and existing products.
  • Assumes a leadership role supporting product development projects. Ensures quality, regulatory and compliance processes and metrics are met and support the needs of the customer.
  • Establishes best-in-class quality goals, performs quality metrics trending and applies problem solving / system improvements to meet these target levels of quality.
  • Use the CAPA system to systematically improve processes and organizational capabilities.
  • Partners with suppliers, contract manufacturers and distributors to secure the highest level of quality throughout the entire supply chain.
  • Maintains knowledge of existing and emerging Biotechnology related regulations, standards, or guidance documents and market requirements. Interprets regulatory rules or rule changes and ensures that they are integrated throughout policies and procedures.
  • Enhance the Quality Management System to ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820, ISO 13485 and the US Pharmacopoeia monographs.
  • Drive harmonization of Business Unit quality management systems with alignment to corporate quality management system.
  • Helps ensure consistent quality and regulatory practices are met throughout all phases of the product life cycle.   
  • Executes high quality, integrated cross-functional plans for projects.  Applies best practices in the development, initiation, planning, execution, control and closing of projects.  Interacts with R&D, Product Management, Operations and Corporate Quality and Regulatory teams.
  • Monitors Business Unit specific regulatory requirements, changes and Good Manufacturing Practices principles to ensure compliance, deliver quality standards and meet customer expectations.
  • Develops strategies, KPI's and written business policies aligned with organizational goals and regulations. Effectively uses Lean tools to drive continuous improvement.
  • Promotes a customer centric culture, proactively seeking ways to improve customer satisfaction.
  • Responsible for developing associates through continuous development planning; Drives successful and measurable employee engagement.
  • Manages timelines, budgets and resource allocations according to the requirements of the business.
  • Substantial contribution to Pall International Quality Management System and related facilities.

Job Requirements



Qualifications

Education, Skills and Experience:
  • Bachelor’s degree in Science, Engineering, Supply Chain, Business or Technical field. Advanced degree preferred.
  • 15+ years’ experience with increasing responsibility in biotechnology, medical device or biopharmaceutical QARA preferred.
  • Minimum of 7+ years managing people in a global environment in a matrix organization.
  • Deep and current knowledge of Quality Management principles in Commercial and Manufacturing environments.
  • Working knowledge of regulatory compliance and appropriate ISO standards relevant to the Biotechnology industry.
  • Solid working knowledge of Lean Six Sigma principles.
  • Proven success of building and leading a team and developing talent.
  • Technical proficiency in Quality and Regulatory processes.
  • Global Business Knowledge – including value added perspective, financial awareness and cost control, industry knowledge, strategic focus and diverse business experience.
  • Minimum of 10 years working effectively in diverse global environments. 
  • Critical thinking and decision-making, analytical problem solving, business astuteness, and process orientation.
  • Results oriented with the ability to balance other business considerations.
  • Strong command of Microsoft Office products:  PowerPoint; Excel, Word.
  • Experience with Quality Management Systems.


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.