Sr. Director, Biotherapies Quality

Company: Vitalant
Location: Scottsdale
Posted on: August 7, 2022

Job Description:

Organization BSI Business GroupPrimary Location United States of America-Arizona-ScottsdaleWork Locations 0101 AZ Scottsdale CO Vitalant 6210 East Oak St. Scottsdale 85257Employee Status Full-time, RegularShift Day JobTravel Yes, 15 % of the TimeJob Posting Close Date Aug 13, 2022Job Function Quality/ComplianceVitalant is where donors, talent and innovation meet to save and improve lives. We are the nation's largest independent, nonprofit blood services provider exclusively focused on providing lifesaving blood and comprehensive transfusion medicine services for about 900 hospitals and their patients across the U.S. We seek team members who want to make a difference in people's lives while furthering their careers. At Vitalant you can expect competitive compensation, paid time off and other benefits. Take your first step to joining our dedicated team by applying today.PRIMARY PURPOSE:Under minimal direction, this position provides support and leadership in advancing performance related to compliance, process improvement, and risk mitigation in the area of Biotherapies, including, but not limited to cellular therapy collections and processing, collection of starting materials for biotherapy treatments, apheresis therapeutic procedures and clinical laboratories such as HLA and Specialty Coag labs. Leads a geographically dispersed team who comprise the quality staff who oversee these activities. This Sr. Director is a highly visible leader, an integral member of the Quality Leadership team, who assures quality in their areas of oversight.DUTIES AND RESPONSIBILITIES:Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.Assures quality customer service to all customers.Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.Hires, supervises, trains, develops, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.Leads through example, demonstrating RITE Values. Provides mentoring, coaching, counseling, and direction to Biotherapies quality staff. Collaborates with staff at regular intervals, fostering an environment of trust with open communication.Conducts process analysis and improvement activities including in-depth data analysis of deviation and operational performance data. Evaluates data for trends and opportunities for improvement. Facilitates and/or leads improvement initiatives including the use of improvement tools and methodologies. Serves as an improvement resource to operational units. Supports cultural transformation through Operational Excellence as it is adopted by the Biotherapies operational units to include being a resource for use of process improvement tools and methodologies.Supports the internal assessment program, participating in development of the assessment schedule and providing resources as needed to perform assessments. Assists operations in evaluating observations, performing investigations, and root cause analysis. Aids in the development of corrective action.Provides leadership to Biotherapies, quality, and operational teams to remain prepared for external agency inspections. Directs the development of responses to external observations. Reviews, approves and ensure timeliness of responses. Assures that both quality and operational follow-up activities are effective and completed.Directs the review of new SOPs and processes, validation review and approval, and review of documents for various operational areas as needed. Support standardization efforts as functions are centralized.Participates in change implementation and evaluates process changes to include, if applicable, planning pre-implementation and post implementation assessments, ensures that required documents for regulatory purposes are collected and submitted.Oversees the deviation management process for their operational functional area, tracking and trending deviations, ensuring deviation reports are accurate and timely, and ensuring corrective actions are appropriate and effective. Participates in, and/or directs quality staff participation in evaluation of non-conforming products, materials or test results and assesses impact on external customersActs as the local Privacy Coordinator. Handles routine local issues and is the primary communications liaison with the Privacy Officer, the Legal Department, and Security Officer. As applicable, serves as the local privacy contact under the Health Insurance Portability and Accountability Act (HIPAA).Assists in oversight of clinical study or research activities.Provides support for safety management in Biotherapies areas, providing safety observations and working with safety staff to implement applicable safety oversight for clinical activities.Remains abreast of changes and developments in their area of Biotherapies related to regulations and standards and provides direction to implement required changes.Establishes and maintains a network of professional relationships and provides feedback and input in professional industry meetings. Maintains sufficient continuing education to support required biotherapy activities.Participates in the annual budget preparation and ensures adherence to approved department budget.Performs document control activities as needed.Performs all other duties, at the discretion of management, as assigned.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 certification in a related Biotherapy field preferred.ExperienceSix years of related experience in a regulated industry required. To include: Four years in a quality, regulatory, and/or assessment environment. Three years supervisory experience. Two years clinical/biotherapy experience in a leadership role.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%+).DIVERSITY, EQUITY & INCLUSION AT VITALANTVitalant is committed to fostering a diverse and inclusive workplace built on a foundation of respect, integrity, teamwork, and excellence. Through our DEI strategic plan, we create opportunities for employees of all backgrounds to feel valued, seen and heard. We believe this mission drives creativity and innovation, as employees experience an environment conducive to personal growth and career development.VITALANT OFFERS A COMPREHENSIVE BENEFITS PACKAGEHealth, Dental and Vision InsuranceHSA, FSA and 401k retirement savings plansPaid Time OffCommuter benefitsEmployee assistance programCOVID-19 POLICYAs an essential operation to the nation's healthcare infrastructure and a science-based organization, Vitalant believes that being vaccinated helps provide protection and care for our employees, our donors, their families, and the broader community. Vitalant requires employees to be fully vaccinated as a condition of employment. Individuals applying for this position should be prepared to comply with the COVID-19 vaccination mandates of Vitalant and accordingly, will need to have received the full series of vaccinations two weeks prior to the first date of employment unless an approved exemption exists prior to start.EEO including disability and veterans

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