Executive Director, Cell Therapy Quality Site Head
Company: Bristol Myers Squibb
Location: Bothell
Posted on: January 12, 2021
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Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science. In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.Job Title:Head of Quality
Cell Therapy Bothell WA Facility, Executive DirectorManager:Vice
President, CTDO QualityDepartment/Group:QualityTravel
Required:5%Location:Bothell, WAJob DescriptionBristol-Myers Squibb
is a global Biopharma company committed to a single mission: to
discover, develop, and deliver innovative medicines focused on
helping millions of patients around the world in disease areas such
as oncology, cardiovascular, immunoscience and fibrosis. Join us
and make a difference. We hire the best people and provide them
with a work environment that places a premium on diversity,
integrity, collaboration and personal development. Through a
culture of inclusion, we create a better, more productive work
environment. We believe that the diverse experiences and
perspectives of all our employees help to drive innovation and
transformative business results.Job SummaryBMS is seeking a Head of
Quality at the BMS Cell Therapy Manufacturing Facility in Bothell
WA. This role will be responsible for leading the day-to-day
Quality operations at the Bothell Cell Therapy site including
Quality Assurance Operations, Quality Systems and Compliance, and
Quality Control. The role will also be a key contributor to the
implementation and execution of BMS's quality systems in
preparation for commercialization of BMS's Cell Therapy
products.This includes but not limited to the implementation of
policies, practices, procedures, standards, and systems necessary
to ensure the compliance of site operations to global GMP
regulations. This individual will be a key leader in the Global
Cell Therapy Quality organization and a champion for quality
principles and compliance within the Bothell Cell Therapy Facility
organization. This individual will be a member of the Bothell
Manufacturing Leadership Team. This role is stationed in Bothell WA
and reports to the Vice President, Cell Therapy Quality.Job
Responsibilities* Responsible for the Quality oversight of GMP
operations at the Bothell Cell Therapy manufacturing facility, and
ensuring adherence to applicable GMP regulations and BMS policies
and procedures* Assure the required processes, procedures, systems
and resources are in place to ensure a compliant disposition of
materials and cell therapy products* Collaborate with other leaders
across the organization and assist in the continuous improvement
and lifecycle management of GMP policies and quality management
system, including providing guidance and direction for
transitioning from clinical to commercial phase GMP operations*
Provide leadership and build an exceptional team to manage the
Quality functions (Quality Assurance, Quality Systems, Quality
Control), including hiring, mentoring and developing personnel*
Work collaboratively with Leads from Facilities and Engineering,
Manufacturing, IT, Patient Operations, MS&T, to ensure
readiness for commercialization at the Bothell facility* Lead the
management review of quality compliance and operational KPIs at the
Bothell manufacturing facility; ensure timely mitigation of
unfavorable trends* Lead the implementation of BMS's Pre-license
inspection readiness plan at the Bothell facility* Provide
expertise and guidance in interpreting governmental regulations,
agency guidelines and internal procedures to assure continued
compliance at the Bothell facility* Lead and host compliance audits
and regulatory inspections by competent regulatory authority (e.g.,
FDA, EMEA, MHRA, etc.)* Develop departmental goals and ensure
timely completion of all deliverables* Champion and foster a
positive and quality compliance culture* Establish and effectively
manage the Bothell Cell Therapy Quality annual operating budget*
Represent and lead Bothell Cell Therapy Quality in the development
of corporate initiatives, harmonization initiatives and
planningQualifications and Education Requirements* BS/MS in
relevant Science or Engineering discipline and 15+ years of
experience in managing Quality functions* Expertise in GMP
compliance and global regulations* Experience in hosting global
regulatory agency inspections and successfully presenting product
and quality compliance programs to regulatory agency reviewers is
required* Experience with implementing and overseeing GMP
operations in a commercial manufacturing facility is required*
Demonstrated Quality leadership through a partnership approach with
manufacturing to enable high quality and compliant product
distribution to patients is required* Background in Biologics or
Cell Therapy Manufacturing is required* Demonstrated experience
building and leading exceptional Quality Assurance, Quality Systems
and Quality Control teams is required* Experience in continuous
improvement, operational excellence and six-sigma is desired*
Demonstrated excellence in written and verbal communication*
Demonstrated ability to work cross-functionally and to develop and
maintain strong business partner relationships * Proven leadership
ability to carry out difficult decisions in a logical, rational
manner, and demonstrated ability to work as a senior management
team member and to engage and influence team members in a matrixed
environmentAround the world, we are passionate about making an
impact on the lives of patients with serious diseases. Empowered to
apply our individual talents and diverse perspectives in an
inclusive culture, our shared values of passion, innovation,
urgency, accountability, inclusion and integrity bring out the
highest potential of each of our colleagues.Bristol Myers Squibb
recognizes the importance of balance and flexibility in our work
environment. We offer a wide variety of competitive benefits,
services and programs that provide our employees with the resources
to pursue their goals, both at work and in their personal
lives.
Keywords: Bristol Myers Squibb, Seattle , Executive Director, Cell Therapy Quality Site Head, Executive , Bothell, Washington
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