Manager, Quality Operations, External Manufacturing Americas
Company: Disability Solutions
Location: New Brunswick
Posted on: May 3, 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:
careers.bms.com/working-with-us .Position Summary The Manager of
Quality Operations will provide Quality and Compliance oversight to
Contract Manufacturing and Packaging Organizations (CMOs) within a
cross-functional team and Product Disposition functionality for
drug products manufactured by CMOs. The primary responsibility of
this role is to ensure that the CMOs are operating in compliance
with all Bristol Myers Squibb (BMS), applicable Food and Drug
Administration (FDA), and international regulatory standards. In
addition, this position has responsibility to ensure that released
products comply with BMS internal and government (FDA or specific
market) requirements and support Quality Services processes (e.g.,
complaint investigations and change controls). Key
Responsibilities:
- Manages CMO relationships from a quality and compliance
perspective, including monitoring quality metrics, performing
annual risk assessment of CMOs and executing oversight as defined
by Standard Operating Procedures (SOP's), authoring and executing
Risk Mitigation Plans as needed
- Determines disposition of drug products according to BMS and
regulatory specifications and standards
- Review change requests generated internally or by External
Manufacturer
- Reviews Annual Product Quality Reviews (APQR's) authored by
Contract Manufacturers/Packagers and supplement APQR's as
required
- Investigate and/or evaluate manufacturing, packaging and
laboratory deviations or incidents and associated Corrective and
Preventive Actions (CAPA's) and provide direction and
recommendations as to future course(s) of action
- Review Quality Agreements
- Review and approve product quality complaint
investigations
- Review and approve validation/qualification protocols and
reports from the External Manufacturer as defined in related
Quality Agreements
- Write, review and implement SOP's to ensure compliance with
current BMS standard and current Good Manufacturing Practices
(cGMP)
- Participate as required on Fact Finding Investigation Team (FIT
and Fact Finding Investigation Review Meetings (FIRM)
- Supports product recalls and executes plan as assigned
- Represent Bristol Myers Squibb during FDA/other regulatory
inspections and corporate Good Manufacturing Practices (GMP)
compliance audits as defined in related Quality Agreements
- Assist with preparation of audit observations
- Participate in audits (For Cause) of North American External
Manufacturers of drug products ensuring compliance with all
appropriate BMS and FDA and European Medicines Agency (EMA) cGMP
regulations and policies
- Represent Quality on cross-functional teams within the "Virtual
Manufacturing Plant", Technical Transfer teams, Supplier Selection,
Serialization Manufacturing and Packaging launch teams Key
Requirements:
- B .S. in Natural Sciences, Chemistry, Microbiology, Biology,
Engineering, Pharmacy or equivalent
- A minimum of five (5) years' experience in pharmaceutical,
biologics, biotech or related industry with relevant
experience
- Experience in a Quality Assurance, Quality Control or
equivalent function is required
- Experience in the manufacture of drug substance and/or drug
product or quality control laboratories is desired
- Knowledge in solid dosage forms, parenteral technology,
biologics or combination products
- Knowledge of compendial and cGMP requirements, FDA regulations
and the ability to interpret and apply them
- Proficiency with the use of global systems (e.g., Systems,
Applications and Products (SAP), Document Control and Archiving
(DCA))
- Good verbal and written communication skills essential
#LI-HybridIf 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 adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility 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.Any data processed in connection with role applications will
be treated in accordance with applicable data privacy policies and
regulations.
Keywords: Disability Solutions, Sayreville , Manager, Quality Operations, External Manufacturing Americas, Executive , New Brunswick, New Jersey
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