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Danaher Corporation Vice President of Quality (Life Sciences) in Westborough, Massachusetts

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 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.

Do you thrive on redefining Quality into a competitive advantage? This position leads Pall Life Science's global Quality organization, ensuring accountability for the performance and results of the business! This position may be located in Westborough, MA; Pensacola, FL; Hauppauge, NY; or Greenville, SC area. Full relocation is available.

Key Responsibilities:

Accountable for the performance of the quality organization including customer satisfaction, on time delivery, compliance, registrations, labeling, relationships with regulators and customers, talent management, and effective communications related to quality initiatives for Pall Life Sciences.

Collaborates with R&D, Product Engineering, Sales and Operations to develop targets for new and existing products.

Lead and supports product development projects. Ensures quality, regulatory and compliance processes and metrics are met and support the needs of the customer.

Establishes goals, performs metrics trending and applies problem solving / system improvements to meet these target levels of quality and improves customer satisfaction.

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 industry 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.

Enhances 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 11 and 820, ISO 13485 and the US Pharmacopoeia monographs.

Applies best practices in the development, initiation, planning, execution, control and closing of projects. Interacts with R&D, Product Management, Operations and Services,

Monitors Business Unit specific regulatory requirements, changes and Good Manufacturing Practices principles to ensure compliance, deliver quality standards and meet customer expectations.

Develops strategies, metrics and written business policies aligned with organizational goals and regulations. Effectively uses Danaher Business System (DBS) tools to drive continuous improvement.

Develops interpersonal capabilities through succession planning, organizational assessment, diversity and inclusion, identification of key skill gaps, talent acquisition, and engagement that link with business goals.

Education and/or Experience

  • Bachelor’s degree in Science, Engineering, Supply Chain, Business or Technical field. Advanced degree preferred.

  • Prefer 15+ years’ experience with growing responsibility in biotechnology, medical device or biopharmaceutical QARA preferred.

  • Prefer 10+ years managing people in a global environment in a matrix organization.

Preferred Requirements:

  • Deep knowledge of Quality Management principles and systems in Commercial and Manufacturing environments.

  • Understanding of regulatory compliance and appropriate ISO standards relevant to the Biotechnology and/or Medical Device industries.

  • Knowledge of Lean Six Sigma principles.

  • Proven success building and leading a team and developing talent.

  • Technical proficiency in Quality and Regulatory processes.

  • Global Business Knowledge – including financial awareness and cost control, industry knowledge, strategic focus and diverse business experience.

  • Critical thinking, decision-making, analytical problem solving, business astuteness, and process orientation.

  • A self-starter with high energy level. Proactive, dynamic, making things happen.

  • Strategic thinker and general manager demeanor; capable of translating business objectives into tactical action plans and achievements.

  • An intelligent, decisive, self-confident and results-oriented individual who possess a combination of mental flexibility, creativity, analytical ability and sound judgment.

  • Outstanding interpersonal skills, and ability to work across functional areas within a company culture that is high performance and leads through lean six sigma principles.

  • Ability to build relationships with leaders, peers and subordinates across a large and global organization.

  • An effective collaborator and relationship builder, able to get results through influencing with and without position power.

  • Able to facilitate objective analyses of alternative points of view and the ability to articulate the strengths and weaknesses of business options in order to reach an informed decision.

  • Willingness to travel globally up to 50% globally when it is safe to do so. Pall now offers unlimited PTO for exempt US associates.

    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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

    Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

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

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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 (https://www.danaher.com/how-we-work/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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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