Manager, External QA, Non-Sterile
Company: Disability Solutions
Location: New Brunswick
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:
.PURPOSE AND SCOPE OF POSITION:The position provides Quality
oversight for the selection of Contract Manufacturing Organizations
(CMOs) used for the manufacture, bulk packaging, testing and
distribution of Clinical Supplies in accordance with corporate
policies, procedures and GMPs. The incumbent will cover multiple
products at the CMOs and will report to the Associate Director,
External QA Lead.DUTIES AND RESPONSIBILITIES
- Oversees the Contract Manufacturing Organization's Quality
Management Systems:
- Partner with Clinical Supply Operations (CSO) and Drug Product
Development (DPD)/Chemical Product Development (CPD) to identify
and qualify manufacturing facilities for the Manufacture, Bulk
Packaging and testing of API and/or Clinical Drug Products.
- Serves as the BMS Quality single point of contact for the
assigned CMOs with responsibility for Quality and Compliance
performance.
- Ensures Deviations, Product Quality Complaints, Change
Controls, 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 CSO / DPD / CPD to identify Quality and
Compliance risks and develop / implement plans to mitigate via a
risk management approach.
- Quality Review and Approval of GMP Documentation:
- Responsible for final Batch Disposition decisions: Reviews, in
a timely manner, all batch and test documentation associated with
Active Pharmaceutical Ingredients and/or Investigational Medicinal
Products (IMPs) and releases those found in compliance into SAP and
QMS as applicable.
- Conducts, plans, schedules the review and approval of GMP
records, data, and other release documentation as needed, intended
for the manufacture of API and IMPs.
- Reviews and approves documents related to Quality Systems such
as master batch records, manufacturing and laboratory investigation
reports, and other documents as needed.
- Provides instruction and guidance on quality issues and serves
as a resource for the site.
- Participates in Corporate Vendor Audits/Visits as
required.
- Provides guidance to the CMC QA teams on quality issues.
- Authors procedural documentation.
- Coordinates and authors Quality Agreements.
- Supports site operations during regulatory agency and
third-party inspections as required.
- Performs Vendor Quality Risk Assessments.
- Performs other tasks as assigned. EDUCATION AND EXPERIENCE
- BS/MS in a Scientific discipline, preferably in Chemistry,
Pharmacy, 2-5 years' experience in the Pharmaceutical industry in a
technical or quality role and may be combined with other relevant
Pharmaceutical industry experience.
- Periods spent in clinical or commercial manufacturing
operations would be considered advantageous. Experience within a
QA/QC environment is an asset.
- Experience within R&D, including Chemical Development
and/or Drug Product Development environment is an asset.
- Experience in the manufacturing of non-sterile drug product and
drug substance.
- General knowledge of GMP operations and regulations. Required
knowledge, skills, abilities:
- Decision-making regarding disposition for distribution of
clinical trial materials and materials for production, based on
documentation review.
- Decision-making where commitment is required on release dates
for product and/or material.
- Works to resolve problem that may arise when a product or
material needs to be released in a short time frame and documents
received are incomplete and/or contain errors.
- Demonstrates initiative to clarify unclear situation in the
presence of documentation irregularities.
- Prioritizes when handling multiple work assignments and
deadlines.
- Works with minimum of supervision.
- Strong interpersonal and organizational skills.
- Demonstrated leadership skills.
- Effective written and verbal communication.
- Computer literacy: Microsoft Office and SAP environment, Veeva,
PDLIMs, and other systems as required (e.g. DeltaV,
Pilotclean).WORKING CONDITIONS: (US Only) PHYSICAL/MENTAL DEMANDS:
(US Only) Work is performed in a typical office environment, with
standard office equipment available and used. Work is generally
performed seated but may require standing and walking for up to 10%
of the time.Approximately up to 10% domestic and/or international
travel, as needed.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, Scranton , Manager, External QA, Non-Sterile, Executive , New Brunswick, Pennsylvania
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