Sr. Director, Clinical Services Quality

Vitalant; Denver (CO); On-site; USD 150,000 - 175,000; Full time

Job summary

Vitalant seeks a Senior Director, Clinical Services Quality to lead quality, regulatory compliance, and risk mitigation across Clinical Services, guiding a geographically dispersed team toward safe, effective operations.

The role drives continuous improvement, SOP development, inspection readiness, deviation management, and CAPA, while serving as Privacy Coordinator and partnering with Legal, Security, and Privacy teams. Salary: $150,000–$175,000 plus incentive eligibility.

Qualifications

• Bachelor's degree required in a related field.
• Six years of experience in a regulated industry.
• Four years in a quality, regulatory, or assessment environment.
• Three years of supervisory experience.
• Two years in a clinical leadership role (clinical laboratory or apheresis).

Responsibilities

• Lead clinical services quality staff and oversee quality, regulatory compliance, and risk mitigation across Clinical Services.
• Drive continuous improvement, audits, and CAPA with data analysis and performance trending.
• Oversee SOP review, validation, and implementation to ensure regulatory compliance and standardization.
• Support privacy and HIPAA compliance as Privacy Coordinator and collaborate with Legal, Security, and Privacy teams.

Skills

Leadership

Quality management

Regulatory compliance

Data analysis

Root cause analysis

SOPs

Privacy & HIPAA

Budget planning

Communication

Travel

Education

Bachelor's degree

SBB/ MLS certification

Job description

At Vitalant, the impact you make doing work that is purposeful, meaningful, and worthwhile is vital. As a member of our non-profit organization, you can be impact-inspired to provide vital clinical services to communities nationwide, vital products to those in need of a donor's generosity, or vital scientific research that advances blood safety worldwide.Work Shift (if applicable):Shift 1 (United States of America)Job Description:At Vitalant, our mission is to save and improve lives through blood donation, research, and innovation. The Sr. Director, Clinical Services Quality plays a critical leadership role in advancing this mission by strengthening quality, compliance, process improvement, and risk mitigation across clinical services. This highly visible leader oversees a geographically dispersed clinical services quality team and serves as an integral member of the Functional Leadership team, ensuring quality standards are upheld and continuous improvement efforts support safe, effective, and reliable operations.Compensation: $150,000 - $175,000 + incentive plan eligibilityLocations: Tempe, AZ; Denver, CO; Rosemont, IL; Allendale, NJ; Montvale, NJ; or Pittsburgh, PAAs the Sr. Director, Clinical Services Quality, you'll get to:Provide strategic leadership to advance quality, regulatory compliance, customer service, operational performance, and risk mitigation across Clinical Services.Lead, mentor, and develop clinical services quality staff, fostering accountability, open communication, collaboration, and alignment with Vitalant’s RITE Values.Drive continuous improvement and Operational Excellence initiatives through data analysis, performance trending, root cause analysis, and the implementation of effective improvement methodologies.Oversee internal assessments, deviation management, investigations, and corrective and preventive actions to ensure issues are addressed effectively and in a timely manner.Lead regulatory inspection readiness, coordinate responses to external agency findings, and ensure timely, effective follow-up on observations and required corrective actions.Direct the review, validation, approval, and implementation of standard operating procedures (SOPs), process documentation, and changes to support regulatory compliance and organizational standardization.Oversee the evaluation of nonconforming products, materials, and test results, assessing potential impacts on external customers and ensuring appropriate resolution.Support privacy and regulatory compliance by serving as the local Privacy Coordinator and partnering with Privacy, Legal, Security, and other stakeholders on applicable requirements, including HIPAA.Provide quality and compliance oversight for clinical studies, research activities, and safety management within Clinical Services.Monitor regulatory and industry developments, assess their impact on clinical operations, and guide the implementation of required changes.Contribute to annual budget planning, monitor expenditures against approved budgets, and oversee document control activities as needed.REQUIREMENTS:KNOWLEDGE/EDUCATIONBachelor's degree required.LICENSES/CERTIFICATIONSCertification as a Medical Technologist, Clinical Laboratory Scientist, or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.EXPERIENCESix years of related experience in a regulated industry required. To include:a. Four years in a quality, regulatory, and/or assessment environment.b. Three years supervisory experience.c. Two years clinical experience in a leadership role (clinical laboratory or apheresis)SKILLS/ABILITIESMust possess the skills and abilities to successfully perform all assigned duties and responsibilities.Must be able to maintain confidentiality.Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate senior and executive-level managers.Effective oral and written business communication skills.Able to organize, prioritize, and execute a variable workload and multiple priorities.Ability to think strategically, synthesize complex business and financial data, and develop innovative solutions.Ability to work in a team environment and participate as an active member of management.Must have analytical, statistical, personal organization, and problem-solving skills.Must have proficient computer skills.Ability to travel (25%+).Location:1524 West 14th Street #120 Tempe, AZ 85281Job Category:Information Technology (IT)Contact Information: [e-mail] you are impact-inspired to help others, and making a difference is vital for you, you'll experience a career built on purpose, a company created to care, and a team committed to lead - together.