Global QA Director - Filters And Single Use Systems

Danaher Westborough , MA 01580

Posted 7 days ago

Are you looking to take the next step in your career?

Pall is looking for a Global Quality Assurance Leader to sit within Biotech and lead all aspects related to Quality Assurance & QMS Compliance within our SUS, Filters portfolio.

We are seeking for a strong leader, an individual able take ownership of the quality management system that meets ISO 9001 and Pall International / corporate requirements, while driving the organization to superior performance results This leader firmly guides the team to guarantee that our products are delivered respecting our high quality standards, ultimately targeting to meet and where possible exceed our Customer's expectations. Furthermore, you will act as a partner with suppliers, customers and members of all departments such as Operations, Sales, Purchasing, Strategic Sourcing, Engineering, R&D, etc.

Responsibilities:

  • Undertake all necessary actions to ascertain that the Biotech Filters sites are aligned with ISO 9001, Pall international & Corporate requirements, all relevant product standards and legislation and / or customer specific requirements;

  • Work in close collaboration with VP QARA Biotech, to roll out and implement CORP Quality Procedures, ensuring the proper communication and training is in place across the sites/areas in scope, when applicable.

  • Drive, plan and supervise customer visits/audits; support the implementation of customer audit program including standard work for customer audits;

  • Participate in R&D meetings as an "executive sponsor" in projects;

  • Lead Biotech Filters customer complaint CAPA and NCR processes; adhere to corporate critical issue and reporting guidelines;

  • Oversee supply management processes, including supplier approval, monitoring and development;

  • Support sites' management reviews meetings in scope, in line with corporate guidance and implement BU Audit program;

  • Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes;

  • Act as a Project Manager in situations related to Customer Complaints affecting products in scope, liaising with the different areas of the organization to mitigate and solve the issue in a timely manner; acts as the senior point of contact to Customer Complaints of the products in scope.

  • Work in close collaboration with peers QA Leaders to foment a Biotech Quality culture of sharing best practices and permanent alignment.

  • Drive and/or support the implementation of Product Quality Review in the portfolio in scope.

  • Maintain key user support resources for QARA software solutions, including Pilgrim;

  • Manage Biotech Filters QARA organization to meet corporate & BU goals; clearly define roles and responsibilities;

  • Oversee coordination of responses to QA related customer questionnaires, requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service;

  • Participate in Customer meetings and visits, representing the QARA Biotech Senior Leadership whenever needed or appropriate.

  • Support implementation of Regional & Biotech specific Regulatory & Market requirements based on input from the Regulatory Affairs department;

  • Customer Advocate / Voice of the Customer. Ensure alignment with customer requirements, where possible. Build and sustain strong relationships with SAM and KAMs.

  • People's manager - Ensure that all P4G/D4G of your team is updated according to the expectations highlighted and communicated by HR.

Education and Competencies:

  • Bachelor's degree in a biological science, engineering, or related scientific field;

  • Experience working in biotech, chemical, pharmaceutical industry, preferably in management/leadership positions;

  • Master's degree in Quality Engineering/Management is a plus;

  • Six Sigma / Lean Manufacturing sound knowledge; strong statistical skills;

  • Strong leadership, collaboration, and influencing skills; demonstrated ability to problem solve and drive positive change;

  • Ability to deal effectively with a diversity of individuals at all organizational levels;

  • Excellent interpersonal, oral, and written communication skills; ability to successfully interact with key internal partners and vendors;

  • Fluent in English, other languages are an asset.

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.

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Global QA Director - Filters And Single Use Systems

Danaher