Associate Director, MSAT - Compliance and Investigations
Company: Disability Solutions
Location: Bothell
Posted on: October 8, 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:
.Position Summary The Associate Director, Compliance and
Investigations, leads a team that provides compliance and
investigations support to the Bothell Cell Therapy Manufacturing
Facility. The Associate Director will build a team and establish
processes for investigations, corrective and preventative actions,
self-inspections, and product complaints. The Associate Director
reports to the Senior Director of Manufacturing Sciences and
Technology . Required Competencies: Knowledge, Skills and
Abilities
- Experience leading investigations, performing root cause
analysis, and identifying corrective and preventative actions.
- Experience in product complaints and with writing sections of
APQRs and/or documents used in regulatory filings is a plus.
- Experience in building and growing an organization into a high
performing team.
- Excellent verbal/written communication skills and ability to
influence at all levels.
- Ability to think strategically and to translate strategy into
actions.
- Ability to prioritize and provide clear direction to team
members in a highly dynamic environment.
- Experience with Operational Excellence/Six Sigma and Lean
Manufacturing is a plus.
- Proficient in cGMPs and multi-national biopharmaceutical/cell
therapy regulations.
- Experience in cell therapy, biologics, or vaccine
manufacturing/support required. Duties and Responsibilities:
- Provides direct supervision of lead investigators and
compliance leads.
- In partnership with Quality Assurance, establishes and executes
the investigations, CAPA, Annual Product Quality Report (APQR) and
product complaints programs.
- Establishes and reports metrics for compliance activities
(investigations, CAPAs, training % completion for compliance
programs). In collaboration with Quality Assurance, provide
oversight of Investigations/CAPA management and tracking to ensure
timely and compliant closure.
- Establish and maintain lead investigators certification
training program.
- Performs review and approval of site and department SOPs.
- Ensure safe and compliant cGMP operations and maintains
permanent inspection readiness. Actively supports regulatory
inspections.
- Interact with other teams including Process Engineering and
Manufacturing Support, Engineering and Facilities, Manufacturing
Operations, Quality Assurance, and Quality Control.
- Stay current with industry trends and BMS standards and
participate in best practice forums consistent with function
responsibilities.
- Represents the Site MSAT Investigations team in
cross-functional forums & projects.
- Performs review and approval of site and department SOPs.
- Hires, integrates, and develops high quality talent who are
capable of delivering against the site & department goals and
objectives.
- Defines and enforces performance measures; provides
developmental feedback and coaching.
- Creates an environment of teamwork, open communication, and a
sense of urgency which enhances unit performance and integration
across site departments.
- Supports organizational strategic goals and objectives that are
linked to the overall company strategy through analytical &
risk-based thinking; Makes recommendations and implements actions
to meet strategic goals & objectives.
- Drives the development of efficient, consistent processes, and
builds a workplace culture of continuous improvement through strong
problem solving/creative skills.
- Identifies and recommends improvements to the organization,
processes, procedures, and the Quality Management System.
- Delivers business results through timely, quality, and
risk-based decision making and advice. Reporting Relationship: The
Associate Director, MSAT Cell Therapy Compliance and
Investigations, reports to the Senior Director, Manufacturing
Science & Technology (MSAT). Qualifications and Education
Requirements:
- Knowledge of science generally attained through studies
resulting in a Bachelor's degree in science, engineering,
biochemistry or related discipline, or its equivalent is
required
- A minimum of 8 years' experience in biopharmaceutical
operations with 2+ years of prior management experience required,
or equivalent combination of experience and education. The starting
compensation for this job is a range from $166,000 to $208,000,
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, Seattle Hill-Silver Firs , Associate Director, MSAT - Compliance and Investigations, Executive , Bothell, Washington
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