Sr. Specialist, External QA CAR T
Posted on: June 15, 2019
Location: Summit, New Jersey, United States
Job Category: Quality
Work Location: 556 Morris Avenue 07901
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular
Sr. QA Specialist, Global QA Supply Chain, CAR-T
External QA, CAR-T
Prerequisites (As Applicable)
BS or MS in related science and 5-8 years of experience in a
Summit West, New Jersey
PURPOSE AND SCOPE OF POSITION:
This position provides assistance for the quality oversight for
suppliers/vendors used to manufacture, package and test Celgene
clinical and commercial CAR-T products in accordance with Celgene
policies, standards, procedures and international cGMP s. The
incumbent will assist with the review and will be responsible for
the coordination and processing of Supplier Deviations and Supplier
Change notifications, as well as various other supplier quality
activities related toraw material, consumable, external labs,
transportation suppliers, etc. used for the manufacture, package
and testing of CAR-T products. To the latter, the incumbent will
also have additional responsibilities that include but are not
limited to, providing quality support to Celgene stakeholders and
SMEs, authoring/revising quality system documents.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Thorough knowledge of cGMP in the Pharma/Biotech industry as
well as FDA, EU, and JP regulatory requirements, ICH/ISO
- Knowledge of CAR-T manufacturing processes and testing is a
- Knowledge of sterile products manufacturing processes and
testing. Knowledge of aseptic manufacturing processes is a plus.
- I risk management knowledge.
- Experience in vendor Quality oversight.
- Thorough knowledge of and competence in core quality processes
- including change control, product complaints, deviations/OOS,
- Excellent investigational and QA problem solving skills e.g.
- Able to interpret problems and effectively prepare surrounding
communication in a productive manner to management and the group
with clarity, brevity, and accuracy.
- Able to recognize and group technical/scientific attributes and
drive science based decisions in most technical areas and to a
deeper level in the specific job function.
- Must have strong authorship and be able to critically review
investigations, interpret results, and generate technical
conclusions consistent with Quality risk management
- Analytical mindset e.g.
- Able to assess vendors quality core processes to ensure
compliance with relevant guidelines and procedures; able to
identify acceptable mitigation actions.
- Able to recognize quality risks and develop contingency
- Able to assess, establish and implement new quality processes
both internally and in partnership with assigned vendors. Able to
author resulting procedures and tools.
- Able to recognize patterns in reported data and communicate
strategic solutions to stake holders cross-functionally.
- Quality performance / continuous improvement oriented e.g.
- Able to track meaningful metrics for assigned activities.
- Able to recognize trends in product data and results.
- Able to assess and recommend improvement measures to processes;
able to drive implementation accordingly.
- Skilled in planning and organizing, building relationships,
innovation management and resource allocation.
- Ability to make independent and objective decisions and to work
under minimal supervision with cross functional teams and partners
- Team spirit. Action-oriented and customer-focused.
- Negotiation and persuasion skills.
- Good knowledge of most common office software (Microsoft
- Good verbal and written communication skills in English a
must.EDUCATION AND EXPERIENCE
- BS or MS or equivalent education in Science, or related
- Minimum 5-8years of experience in a pharmaceutical/
biopharmaceutical environment including previous QA experience e.g.
QA compliance role, vendor oversight, batch record review, lot
disposition. Team management experience a plus.DUTIES AND
The position holder is responsible and accountable for the tasks
given below (non-exhaustive list):
- Quality oversight of the activities and services provided by
- Serves as the Celgene QA single point of contact for suppliers
for CAR-T program.
- Assists with supplier qualification activities of new and
current suppliers in support of Clinical and Commercial
- Initiate and Manager Supplier Quality risk assessments.
- Create / negotiate and maintain Quality Agreements.
- Work closely with the suppliers and involve SMEs to ensure
proper and timely resolution of Deviations, Complaint
investigations and CAPAs; ensures properly documented per Celgene
- Evaluate and communicate supplier quality related changes,
ensuring assessment per Celgene change control procedures and
documented in a timely fashion.
- Collect APR-PQR related information and data per Celgene
- Participate in Celgene audits at suppliers, as needed. Travel
could be up to 30%.
- Coordinate / Support the Supplier Quality Review Board to
promote discussions surrounding Supplier Quality Vendor Changes and
Supplier Issue, as well as the approval process for new
- Measure supplier quality performance, periodically collect and
share quality performance metrics. Identify potential trends,
working closely with supplier to define possible areas for
improvement and associated implementation plan.
- Collect supplier quality documentation necessary to support
- Hold appropriate periodic quality meetings with supplier
representatives, as needed.
- Hold or actively participate in joint periodic meetings with
- Contribute to Change control, complaints, deviations/OOS and
CAPA management in electronic system - e.g. support and quality
guidance to record owners, follow up until completion, owner role
as appropriate, closure in a timely manner.
- Partner with CAR-T stakeholders to assess overall supplier
performance, including identifying product-specific quality and
compliance risks and develop mitigation plans based on a risk based
- Provide timely support and necessary information to QA
colleagues and Quality/Supply Chain Management as required.
- Act as representation for Quality Operations as required,
escalate critical issues to Management as appropriate.
- Author necessary quality system documents; review and update
procedures for Celgene Quality Management System per process
- Support Health Authority inspections and audits of the site,
act as QA representative (SME) for functional area relevant
- Participate as QA representative to internal work streams,
projects and improvement initiatives.DEFINITIONS AND
APR-PQR Annual Product Review / Product Quality Review
CAPA Corrective Action Preventive Action
CMO Contract Manufacturing Organization
OOS Out of Specification
SME Subject Matter Expert
This job description is intended to describe the general nature and
level of work being performed by the person assigned to this
position. The primary duties and responsibilities are intended to
describe those functions that are essential to the performance of
This job description does not state or imply that the above are the
only duties and responsibilities assigned to this position. There
are other duties and responsibilities that are considered
incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any
other job-related duties as requested by management.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing
drugs for our patients. Our vision as a company is to build a major
global biopharmaceutical corporation while focusing on the
discovery, the development, and the commercialization of products
for the treatment of cancer and other severe, immune, inflammatory
\"At Celgene, we seek to deliver truly innovative and life-changing
drugs for our patients.\"
There are more than 300 clinical trials at major medical centers
using compounds from Celgene. Investigational compounds are being
studied for patients with incurable hematological and solid tumor
cancers, including multiple myeloma, myelodysplastic syndromes,
chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL),
triple-negative breast cancer and pancreatic cancer. As committed
as we are to clinical accomplishment, we are equally committed to
patient support, which is a guiding principle at Celgene. We
believe all who can benefit from our discoveries should have the
opportunity to do so. Celgene puts patients first with
industry-leading programs that provide information, support and
access to our innovative therapies. Associated topics: automation,
process, prevent, prevention, qa, quality assurance, quality
assurance analyst, software quality, test, test engineer
Keywords: Celgene, New York , Sr. Specialist, External QA CAR T, Other , Summit, New York
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