Director, Quality ExcellenceLocation: 100% Remote
Travel: 20-30% travel within the US
About the RoleWe 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 ResponsibilitiesStrategic 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.
QualificationsEducation- 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. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Third Party Agency and Recruiter Notice:Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Location: NORTH AMERICA : USA : Home Office:USHOME - Home Address US 
