Director of Quality Excellence

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $177k - $265.5k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Grifols

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1909

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. They focus on the development, production, and distribution of innovative plasma-derived medicines and have a strong commitment to research and development in the pharmaceutical sector. Grifols aims to provide solutions for patients with rare diseases and chronic conditions, contributing significantly to the field of biotechnology and healthcare.

📋 Description

• Lead critical Quality initiatives and ensure projects are executed with appropriate compliance across the U.S. plasma donor center network • Ensure consistent compliance with FDA, PPTA, and other regulatory requirements • Provide leadership and oversight of continuous improvements, projects, Biosupplies, RSPTO laboratory, and other quality and business needs related to plasma procurement • Support the development and leadership of a national Quality Operations team • Partner with Quality, Medical, and Operations leadership to establish and execute strategic quality objectives • Drive quality-related continuous improvement initiatives and business-critical projects • Promote collaboration across Operations, Medical, Regulatory Affairs, and Quality functions • Ensure donor center compliance with FDA, PPTA IQPP, CLIA/COLA, state, and other applicable regulations • Identify systemic quality risks and implement corrective and preventive actions • Ensure procedures remain current, compliant, and consistently applied • Support harmonization and standardization of quality processes across donor centers • Monitor product quality trends and key performance indicators • Create processes and procedures to improve compliance and consistency from product collection to distribution • Lead process optimization efforts to improve efficiency, compliance, and product quality • Lead and develop traveling quality teams, laboratory staff, and center staff • Foster a proactive quality culture focused on accountability, compliance, and continuous improvement • Ensure ongoing training, coaching, and competency development of quality professionals

🎯 Requirements

• Bachelor's degree in Life Sciences, Biology, Pharmacy, Nursing, or a related field required • Master's degree preferred • 10+ years of experience in Quality within GxP-regulated, plasma, biologics, pharmaceutical, biotechnology, or related healthcare environments • 5+ years of leadership experience overseeing multi-site Quality Operations teams • Demonstrated success managing FDA, PPTA, EMA, CLIA/COLA, state inspections, audits, and regulatory interactions • Experience with Quality Management Systems such as TrackWise or similar platforms • Proven ability to lead cross-functional quality and process improvement initiatives • Extensive knowledge of FDA, EMA, PPTA, WHO, and applicable regulatory requirements • Strong leadership, coaching, and team development skills • Expertise in risk management, deviation investigations, CAPA, and root cause analysis • Analytical, data-driven mindset with strong decision-making capabilities • Excellent communication, influencing, and stakeholder management skills • Demonstrated ability to drive operational excellence and continuous improvement

🏖️ Benefits

• Up to 30% of the company bonus pool • Medical insurance • Dental insurance • Vision insurance • Life insurance • PTO • Paid holidays • Up to 5% 401(k) match • Tuition reimbursement • Professional growth and career progression opportunities • 100% remote work • Travel within the US (20–30%)