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VP COE Quality & Compliance Systems - Pharma and Med Device

ECOLAB
United States, Pennsylvania, King of Prussia
Dec 16, 2024

The VP COE Quality & Compliance Systems is responsible for the Quality Systems vision and strategy within Ecolab's Bioprocessing and Purification Technologies (BPT), Pharma and Personal Care (PPC) and Healthcare divisions. This role provides Quality leadership to these business segments and is critical in establishing and executing policies, implementing best practices, and optimizing systems to sustain global quality across Ecolab's highly regulated focus areas, ensuring patient safety and growth of the business. The successful candidate will be an established, proactive, dynamic Quality Leader experienced in Pharma and Life Science markets. This individual will be a key leader in Ecolab's Quality network and a close partner for Regulatory/Compliance, RDE, Supply Chain, and the entire Business team. The VP reports to the SVP of Ecolab's Global Technical Organization and indirectly to the SVP Global Regulatory Affairs.

What You Will Do:

  • Development of a vision and strategy for BPT, PPC and Healthcare Quality Systems
  • Partner with the business and technical teams to implement an organizational culture that embeds Quality as a foundation of the business
  • Drive QMS process changes/improvements to meet customer quality expectations and comply with global requirements
  • Provide leadership for design controls, post-market vigilance, supplier controls and all associated processes, such as CAPA, complaints, audits (internal and external)

Additional Responsibilities:

  • Benchmark industry/Ecolab best practices and optimize the quality organization including organizational design, QMS and talent development
  • Assure the Quality System complies with all relevant quality and regulatory requirements where products are manufactured, marketed and distributed; Assure alignment with Ecolab quality policies
  • Proactively consider and respond to customer feedback; assure resolutions (CAPA) are in place that satisfy customer and regulatory needs and deliver continuous improvement
  • Assure all new or modified products are supported by current design and quality plans in keeping with customer, regulatory and supply chain requirements
  • Develop capabilities to enable and support new business lines, processing or material changes that help improve the cost or quality of product offerings
  • Develop customer and regulator audit capabilities that are well-understood, streamlined and provide a competitive advantage
  • Develop best in class regulatory and supplier audit programs and processes

Minimum Qualifications:

  • Demonstrated leadership in driving excellence in quality and change management where critical to consumer, regulatory, customer and business success
  • B.S. degree in technical field, such as engineering, biology, microbiology, or chemistry
  • 15 years of experience in the pharmaceutical or biotechnology industry in quality or compliance positions of increasing technical and leadership responsibility
  • 10 years of experience in people management
  • Previous executive level role with complete responsibility for a Quality System for 3 years+ in a Life Science or Health Care business
  • Experience in meeting global Pharma regulations and inspection expectations
  • Experience working directly with FDA, Notified Bodies and other geographic regulators
  • Experience in leading a global organization
  • Strategic mindset, customer/patient focused risk assessment and judgement
  • Effective relationship management, ability to network, support and influence across the entire organization
  • A history of driving continuous improvement and investment in high growth businesses

Preferred Qualifications:

  • Master's degree (technical field or MBA)
  • LSS Black Belt certification
  • Responsibility for a Quality System in a business >$200 million, preferably >$1 billion
  • A history of leading teams through successful integrations

Benefits

Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families.Click here to see our benefits.

If you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here.

Potential Customer Requirements Notice

To meet customer requirements and comply with local or state regulations, applicants for certain customer-facing roles may need to:

  • Undergo additional background screens and/or drug/alcohol testing for customer credentialing.

  • Be fully vaccinated for COVID-19, including a booster if eligible, unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.

Americans with Disabilities Act (ADA)

Ecolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website.

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