Director, Quality IT Data Integrity Cell Therapy
Company: Adecco Group
Posted on: April 8, 2021
Director, Quality IT Data Integrity Cell Therapy
- Bothell, Washington
- Qlty Assurance Methods
- Full Time
- 2021-03-21T00:00:00+0000 mail_outlineGet future jobs matching
this search or 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
Overview: The Director of Quality IT/DI will provide QA oversight
of electronic data systems used in support of GMP operations
throughout their lifecycle at the Bothell Manufacturing Facility.
In addition, in collaborative partnership with IT and Validation,
this role us responsible for identifying, proposing, defining user
requirements and implementing integrated electronic data systems
that improve the effectiveness, efficiency and cGMP compliant Data
Integrity in a cGMP facility. This includes electronic
spreadsheets, laboratory and manufacturing data acquisition systems
and IT controlled manufacturing equipment. This role is also
responsible for promoting and fostering an operational excellence
culture within the manufacturing facility, trending of compliance
and operational key performance indicators (KPIs) for site IT and
DI initiatives, identifying and driving continuous improvement to
ensure the Quality Unit adequately fulfills its regulatory
compliance responsibility and ensuring patient safety in a
productive and efficient operational model. Key Responsibilities:
- Review and approve policies, procedures, validation
documentation for e-systems used across the cGMP manufacturing and
laboratory operations. Serve as the site DI subject matter expert
(SME) and promote/train/coach site staff on ALCOA principles and
associate worldwide regulations.
- Ensure the validation, implementation and change management of
e-systems used across the site operations are conducted in
compliance with applicable regulatory requirements (FDA, EMA,
- Act as business/process owner for the implementation of
technology solutions for processes used across the Quality Control
and Facility operations including QMS, LIMS, LMS, equipment-LIMS
interfacing, testing/liquid handling automation system,
manufacturing control systems and data acquisition systems.
- Effectively partner with IT, Validation and other key
stakeholders to ensure a compliant management of the e-systems
- Automate data gathering, processing and information management
in support of Quality compliance and operational KPIs trending;
issue periodic trending reports.
- Drive continuous improvement to enhance productivity and
efficiency of operations across the site.
- Work closely with site support departments such as OE,
Manufacturing Compliance, MSAT, to develop in-house expertise with
Lean process improvement and promoting a Lean culture.
- Support other Quality functions with resource modeling in
support of commercial inspection readiness.
- Serve as subject matter expert for QA oversight of e-systems
during regulatory inspections.
- Collaborate with corporate teams to ensure adherence to company
policy and site SOP's. Key Requirements
- BS or higher degree in an IT, engineering, scientific
discipline or other related field.
- Fifteen (15) or more years of experience in pharmaceutical
quality operations, quality assurance, quality systems, and/or IT
compliance role with at least 3+ years in a leadership
- Expertise with 21 CFR Part 11 and GAMP standards for validation
of automated systems is required.
- Experience with QA oversight of e-systems for GMP operations is
- Demonstrated excellence in written and verbal
- Demonstrated ability to work cross-functionally and to develop
and maintain strong business partner relationships.
- Demonstrated ability to work effectively with US FDA and other
regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP,
ISO and other applicable standards.
- Demonstrated record with driving continuous improvement and
fostering a compliant operational excellence culture.
- Proven leadership ability to carry out difficult decisions in a
logical, rational manner, and demonstrated ability to work as a
leader of team(s) to engage and influence team members in a
matrixed environment. BMSCART Around 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
Our company is committed to ensuring that people with disabilities
can excel through a transparent recruitment process, reasonable
workplace adjustments and ongoing support in their roles.
Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application, or any part of the recruitment process
direct your inquiries to firstname.lastname@example.org. Visit
careers.bms.com/eeo-accessibility to access our complete Equal
Employment Opportunity statement.
Keywords: Adecco Group, Seattle , Director, Quality IT Data Integrity Cell Therapy, Executive , Bothell, Washington
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