Director, QA Disposition
Company: Disability Solutions
Location: Bothell
Posted on: October 2, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.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. Read more:
.PURPOSE AND SCOPE OF POSITION: The Director of Quality Assurance
Lot Disposition is a full-time position located at the BMS Cell
Therapy Manufacturing Plant in Bothell, WA. The primary focus for
this role is to lead the QA Lot Disposition team to ensure final
drug products and raw materials are released to market following
all BMS internal procedures and cGMP requirements. Included in the
area of responsibilities is final drug product disposition, raw
material disposition, lead the Cell Therapy Material Review Board
(MRB), and Quality Master Data oversight. This person will be a key
leader on of the site Quality Leadership Team and a champion for
quality principles and compliance within the BMS Bothell
organization. This position reports directly to the Head of
Quality.QUALIFICATION REQUIREMENTS:
- Bachelors or Masters degree in relevant Science or Engineering
discipline
- 12+ years of experience in managing Quality functions; at
minimum 8 years of people management experience. Or relevant
combined education and industry experience.
- Background in commercial biologics is required with Cell
Therapy Manufacturing experience preferred.
- Experience in both clinical and commercial GMP operations is
preferred. Key Knowledge, Skills, and Abilities
- Expertise in GMP compliance and FDA/EMA regulations.
- Demonstrated experience building and leading exceptional teams
is required.
- Demonstrated excellence in written and verbal
communication.
- Demonstrated ability to work cross-functionally and to develop
and maintain strong business partner relationships.
- Proven experience working as a detailed oriented team player
with effective planning, organization and execution skills.
- 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 environment.ROLES AND RESPONSIBILITIES:
- Ensure timely product disposition; manage the lot disposition
activities for finished Cell Therapy drug products and raw
materials by ensuring all relevant documentation associated with a
lot are accounted for, completed and approved by the appropriate
individuals.
- Collaborate with stakeholders and management and communicate
lot disposition status; monitor progress and issue status
reports.
- Lead Cell Therapy Material Review Board (MRB) meetings and
evaluate recommendations made by the board during product
disposition.
- Must be able to interpret problems and effectively prepare
surrounding communication in a productive manner to management and
the group with clarity, brevity, and accuracy.
- Act as a key contributor to the BMS Cell Therapy lot
disposition and MRB community of practice.
- Collaborate with other leaders across the organization and
assist in the continuous improvement and lifecycle management of
implemented cGMP policies and quality management systems.
- Develop departmental goals and ensure the timely completion of
all deliverables.
- Champion and foster a positive and successful quality culture,
aligned with BMS' existing culture and values.
- Mentor Quality personnel and enable their individual
growth.
- Interface and act as a subject matter expert for QA lot
disposition oversight of cGMP operations during audits and
regulatory inspections.
- Represent the Quality unit at various project meetings and
provide quality input in the resolution of quality-related
issues.
- Work to develop a high performing team delivering performance
at a high degree of accuracy.The starting compensation for this job
is a range from $194,000 to $242,000, plus incentive cash and stock
opportunities (based on eligibility). The starting pay rate takes
into account characteristics of the job, such as required skills
and where the job is performed. Final, individual compensation will
be decided based on demonstrated experience. Eligibility for
specific benefits listed on our careers site may vary based on the
job and location. For more on benefits, please visit our .Benefit
offerings are subject to the terms and conditions of the applicable
plans then in effect and may include the following: Medical,
pharmacy, dental and vision care. Wellbeing support such as the BMS
Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K). Financial protection
benefits such as short- and long-term disability, life insurance,
supplemental health insurance, business travel protection and
survivor support. Work-life programs include paid national holidays
and optional holidays, Global Shutdown days between Christmas and
New Year's holiday, up to 120 hours of paid vacation, up to two (2)
paid days to volunteer, sick time off, and summer hours
flexibility. Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement,
fertility/infertility benefits, support for traveling mothers, and
child, elder and pet care resources. Other perks like tuition
reimbursement and a recognition program. If you come across a role
that intrigues you but doesn't perfectly line up with your resume,
we encourage you to apply anyway. You could be one step away from
work that will transform your life and career. Uniquely Interesting
Work, Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Kent , Director, QA Disposition, Executive , Bothell, Washington
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