Director of Quality Excellence

Grifols; Kansas; Hybrid; USD 177,000 - 266,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

5% 401(K) match

Tuition reimbursement

Job summary

Grifols is seeking a Director of Quality Excellence to guide quality initiatives across its U.S. plasma donor center network, ensuring FDA, PPTA, and other regulatory compliance while fostering a culture of continuous improvement and operational excellence.

The role leads cross-functional teams, drives risk management, CAPA, and process standardization from collection to distribution, mentoring traveling quality staff. Remote work with 20-30% travel within the US is offered.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years in Quality within regulated environments.
• 5+ years leading multi-site Quality Operations.

Responsibilities

• Lead national Quality Operations team.
• Ensure FDA, PPTA, CLIA/COLA compliance.
• Drive continuous improvement initiatives.
• Harmonize quality processes across donor centers.
• Oversee regulatory inspections and CAPA activity.

Skills

Leadership

Quality Assurance

GxP

Regulatory

Data analysis

Stakeholder mgmt

Education

Bachelor's in Life Sciences

Master's preferred

Tools

TrackWise

Quality Mgmt Systems

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Director, Quality Excellence

Location: 100% Remote

Travel: 20-30% travel within the US

About The Role

We are seeking a strategic and results‑driven Director of Quality Excellence to lead critical Quality initiatives and ensure projects are executed with appropriate compliance across our U.S. plasma donor center network. This role ensures consistent compliance with FDA, PPTA, and other regulatory requirements while fostering a culture of quality, donor safety, continuous improvement, and operational excellence. The Director of Quality Excellence will provide leadership and oversight of continuous improvements, projects, Biosupplies, RSPTO laboratory, and other quality and business needs related to plasma procurement.

Key Responsibilities

Strategic Leadership

• 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 and alignment across Operations, Medical, Regulatory Affairs, and Quality functions.

Compliance & Quality Oversight

• 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.

Quality Management Systems

• Ensure procedures remain current, compliant, and consistently applied across the organization.
• Support harmonization and standardization of quality processes across all donor centers.

Product Quality & Operational Excellence

• Monitor product quality trends and key performance indicators.
• Create process and procedures to improve compliance and consistency across donor centers and from product collection to distribution.
• Lead process optimization efforts to improve efficiency, compliance, and product quality.

People Leadership & Quality Culture

• Lead and develop traveling quality teams as well as Lab 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.

Qualifications

Education

• Bachelor's degree in Life Sciences, Biology, Pharmacy, Nursing, or a related field required.
• Master's degree preferred

Experience

• 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.

Knowledge, Skills & Abilities

• 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.

The estimated pay scale for the Director of Quality Excellence role based remotely in the East Coast United States is $177,000.00 - $265,500.00 per year. Additionally, the position is eligible to participate in up to 30% of the company bonus pool.

Benefits

• Medical
• Dental
• Vision
• Life insurance
• PTO
• Paid holidays
• Up to 5% 401(K) match
• Tuition reimbursement

Equal Employment Opportunity

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location

NORTH AMERICA : USA : Home Office:USHOME - Home Address US

Learn more about Grifols