Manager. External Manufacturing QA, Packaging & Labeling
Company: Bristol Myers Squibb
Location: Summit
Posted on: January 27, 2023
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Job Description:
Working with Us
Challenging. 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:
careers.bms.com/working-with-us
The External Manufacturing Quality Manager will provide Quality
oversight for the selection of contract manufacturing organizations
used for the manufacture, packaging, testing and distribution of
Clinical Supplies in accordance with corporate policies, procedures
and GMPs. The incumbent will cover multiple products at the
Contract Service Provider (CSPs) and will report to the Associate
Director, External Manufacturing QA Lead.
Key Responsibilities and Major Duties
Oversees the Vendor Quality Management Systems:
Partner with Technical Operations to identify and qualify
manufacturing facilities for the Manufacture, Packaging and testing
of Clinical Products.
Serves as the BMS Quality single point of contact for the assigned
CSPs with responsibility for Quality and Compliance
performance.
Ensures Complaints, Deviations, Stability and CAPAs are managed in
a compliant and timely manner.
Oversees vendor change control process and ensures that BMS
products are manufactured in full compliance with all applicable
regulations.
Implement the process to achieve Vendor Quality Qualification with
appropriate continued monitoring to ensure maintenance of
status.
Partners with Technical Operations to identify Quality and
Compliance risks and develop / implement plans to mitigate via a
risk management approach.
Develop Quality metrics as part of a balanced scorecard to assess
ongoing monthly performance.
Final Quality approver for all GMP documentation associated with
Batch Records, Investigation Protocols etc.
Participates in Corporate Vendor Audits/Visits.
Key Requirements:
BS/MS in a Scientific discipline, preferably in Chemistry or
Pharmacy. 3 years' experience in Pharmaceutical quality and may be
combined with relevant Pharmaceutical industry experience.
Hands-on CMC experience of clinical manufacturing and/or packaging.
Periods spent in Clinical manufacturing operations would be
considered advantageous.
Experience managing external vendor is required.
Ability to work independently and with cross-functional matrix
team.
In-depth knowledge and understanding of GMP and Quality
regulations.
#LI-Hybrid
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 Careers
With 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
Physical presence at the BMS worksite or physical presence in the
field is a necessary job function of this role, which the Company
deems critical to collaboration, innovation, productivity, employee
well-being and engagement, and it enhances the Company culture.
COVID-19 Information
To protect the safety of our workforce, customers, patients and
communities, the policy of the Company requires all employees and
workers in the U.S. and Puerto Rico to be fully vaccinated against
COVID-19, unless they have received an exception based on an
approved request for a medical or religious reasonable
accommodation. -Therefore, all BMS applicants seeking a role
located in the U.S. and Puerto Rico must confirm that they have
already received or are willing to receive the full COVID-19
vaccination by their start date as a qualification of the role and
condition of employment. -This requirement is subject to state and
local law restrictions and may not be applicable to employees
working in certain jurisdictions such as Montana. This requirement
is also subject to discussions with collective bargaining
representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can
perform complex functions through a transparent recruitment
process, reasonable workplace adjustments and ongoing support in
their roles. Applicants can request an accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application, or in any part of the recruitment
process, direct your inquiries to adastaffingsupport@bms.com .
Visit careers.bms.com/ eeo -accessibility to access our complete
Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your
area.
Any data processed in connection with role applications will be
treated in accordance with applicable data privacy policies and
regulations.
Keywords: Bristol Myers Squibb, New York , Manager. External Manufacturing QA, Packaging & Labeling, Executive , Summit, New York
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