Sr. Director, Biotherapies Quality
Company: Vitalant
Location: Scottsdale
Posted on: August 7, 2022
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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
Keywords: Vitalant, Scottsdale , Sr. Director, Biotherapies Quality, Executive , Scottsdale, Arizona
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