Director of Quality Excellence

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead essential quality initiatives and ensure that projects are carried out with the necessary compliance throughout the U.S. plasma donor center network.

• Maintain consistent adherence to FDA, PPTA, and other regulatory standards.

• Provide leadership and oversight for continuous improvements, projects, Biosupplies, RSPTO laboratory, and various quality and business requirements related to plasma procurement.

• Support the development and leadership of a nationwide Quality Operations team.

• Collaborate with Quality, Medical, and Operations leadership to identify and implement strategic quality objectives.

• Propel quality-related continuous improvement initiatives and business-critical projects.

• Encourage collaboration among Operations, Medical, Regulatory Affairs, and Quality functions.

• Ensure compliance of donor centers with FDA, PPTA IQPP, CLIA/COLA, state, and other relevant regulations.

• Identify systemic quality risks and execute corrective and preventive measures.

• Ensure that procedures are kept up-to-date, compliant, and consistently applied.

• Support the harmonization and standardization of quality processes across donor centers.

• Monitor product quality trends and key performance indicators.

• Develop processes and procedures aimed at enhancing compliance and consistency from product collection to distribution.

• Lead efforts in process optimization to enhance efficiency, compliance, and product quality.

• Direct and develop traveling quality teams, laboratory staff, and center personnel.

• Cultivate a proactive quality culture centered on accountability, compliance, and ongoing improvement.

• Ensure continuous training, coaching, and competency development for quality professionals.

⛳️ Requirements

• A bachelor's degree in Life Sciences, Biology, Pharmacy, Nursing, or a related field is required.

• A master's degree is preferred.

• Over 10 years of experience in Quality within GxP-regulated environments, including plasma, biologics, pharmaceuticals, biotechnology, or other healthcare settings.

• More than 5 years of leadership experience overseeing multi-site Quality Operations teams.

• Proven success in managing FDA, PPTA, EMA, CLIA/COLA, state inspections, audits, and regulatory interactions.

• Familiarity with Quality Management Systems such as TrackWise or equivalent platforms.

• Demonstrated ability to lead cross-functional quality and process improvement initiatives.

• Extensive knowledge of FDA, EMA, PPTA, WHO, and relevant regulatory requirements.

• Strong leadership, coaching, and team development capabilities.

• Expertise in risk management, deviation investigations, CAPA, and root cause analysis.

• Analytical, data-driven mindset with robust decision-making skills.

• Exceptional communication, influencing, and stakeholder management abilities.

• Proven track record in driving operational excellence and continuous improvement.

🏝️ Benefits

• Up to 30% of the company bonus pool.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Paid time off (PTO).

• Paid holidays.

• Up to 5% 401(k) match.

• Tuition reimbursement.

• Opportunities for professional growth and career advancement.

• 100% remote work.

• Travel within the U.S. (20–30%).