VP, Quality and Regulatory Affairs

Job content

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Pall have a really exciting opportunity for a VP Quality and Regulatory Affairs to be based in Switzerland where you will also be travelling to the UK, US and Europe.

The Opportunity:

This is a senior management position 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 Quality and Regulatory Affairs organisation. Promoting a company-wide culture of quality excellence and an understanding of the key elements related to quality systems, this role partners with Operations leaders to foster a culture that focus on both quality and on-time-delivery.

Other Key Responsibilities:

• Accountable for the performance and results related to the roles and responsibilities of the quality and regulatory affairs organizations, including compliance, registrations, relationships with regulators and customers, talent management, organizational development and effective communications across Pall’s Biotechnology Business Unit.
• Assumes a leadership role supporting product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing. 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
• Systematically improve processes and organisational capabilities.
• Maintains knowledge of existing and emerging regulations, standards, or guidance documents.
• Comprehensive knowledge of Quality Systems, which 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 and ISO 13485.
• Helps ensure consistent quality and regulatory practices are met throughout all phases of the product life cycle.
• Monitors Business Unit specific regulatory requirements, changes and Good Manufacturing Practices
• Develops strategies, KPI’s and written business policies aligned with organizational goals and regulations. Effectively uses Danaher Business System (DBS) 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, driving successful and employee engagement.
  

Education and/or Experience

• Bachelor’s degree in a Scientific subject area - Engineering/Technical degrees may also be considered
• 15 or more years’ with increasing responsibility in biotechnology, medical or biopharmaceutical QARA preferred.
• Several years leading large teams of people with indirect and direct reports, in a global environment in a matrix organization
• Shown success of building and leading a team and developing talent.
• Experienced within the pharmaceutical, Biopharm, medical device or similar industries
• Exposure to Quality Management principles in Commercial and Manufacturing environments.
• Strong working knowledge of Lean Six Sigma principles.
• Technical proficiency in Quality & Regulatory processes.
• Global Business Knowledge – including value added perspective, financial awareness and cost control, industry knowledge, strategic focus and diverse business experience.
• Experience working effectively in diverse global environments.
• Results oriented with the ability to balance other business considerations.
• Proactive, dynamic, making things "happen."
• Strong strategic problem solver and general manager attitude; capable of translating business objectives into tactical action plans and achievements.
• Outstanding interpersonal skills, and ability to work across functional areas within a company culture
• Entrepreneurial spirit, with a hands-on mentality and a structured, pragmatic approach.
• Ability and willingness to travel up to 50% to the US, UK and other countries in Europe.
  

Are you interested? Join the PALL Team!

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

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.