Sr. Director, Clinical Services Quality

Vitalant•Allendale, NJ

5d•$150,000 - $175,000•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Certification as a Medical Technologist, Clinical Laboratory Scientist, or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.

Responsibilities

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.