Sr. Manager, Quality Operations
Company: GenScript
Location: Pennington
Posted on: March 13, 2026
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Job Description:
About GenScript GenScript Biotech Corporation (Stock Code:
1548.HK) is a global biotechnology group. Founded in 2002,
GenScript has an established global presence across North America,
Europe, the Greater China, and Asia Pacific. GenScript's businesses
encompass four major categories based on its leading gene synthesis
technology, including operation as a Life Science CRO, enzyme and
synthetic biology products, biologics development and
manufacturing, and cell therapy. GenScript is committed to striving
towards its vision of being the most reliable biotech company in
the world to make humans and nature healthier through
biotechnology. Sr. Manager, Quality Operations Job Scope The Senior
Manager, Quality Operations is responsible for Manufacturing & QC
Shop-Floor Quality, Batch Release, Document Control, and Training
functions. He/She oversees the group responsible for quality
functions related to Good Manufacturing Practices (GMP) and
Phase-Appropriate compliance for both clinical and marketed Gene
Therapy products and Plasmid DNA at the Hopewell manufacturing
facility. He/She is expected to grow and develop the group
commensurate with the business need. Essential Responsibilities:
Leads ProBio’s Quality Operations and Batch Release Program for
Gene Therapy and Plasmid Manufacturing. This may include, but may
not be limited to the following functions: Oversees ProBio’s QA
Area Release/ Line Clearance Procedures and facility walkthroughs.
Oversees Document control activities related to approval of local
electronic documents such as SOPs, Standards, Forms, Work
Instructions, Master Batch Records, and specifications. Oversees
issuance and control of logbooks, laboratory notebooks, master
batch records, controlled forms. Develops and implements local
procedures for control of drug product label proofs, printed
labels, and reconciliation of unused/damaged labels. Develop and
oversee training program to include role-based curricula and
personnel qualification program Manage Veeva Vault administration
for all Veeva Vault applications. Recommends Quality system changes
to enhance overall job performance and Quality functions and
partners with peers in overseeing the implementation of these
changes Manage, coach and mentor direct reports. Performs other
tasks and assignments as needed and specified by management.
Qualifications: Bachelor’s degree in a scientific discipline and a
minimum 7 years of experience in Quality or related role(s) in a
pharmaceutical, biotechnology or related environment, and at least
3 of which have been in a CMC-focused Quality position. Experience
with Veeva Vault Quality Docs and Training Proficiency with
Microsoft Office. Excellent verbal and written communication
skills. Ability to work independently and collaboratively, as
required, in a fast-paced, matrixed, team environment consisting of
internal and external team members. Analytical thinker with
excellent problem-solving skills and the ability to adapt to
changing priorities and deadlines. Demonstrated knowledge of
biologics, viral vector, and plasmid manufacturing and testing. LW
PB GenScript USA Inc/ProBio Inc. is a proud equal
opportunity/affirmative action employer committed to attracting,
retaining, and maximizing the performance of a diverse and
inclusive workforce. It is the Company's policy to ensure equal
employment opportunity without discrimination or harassment based
on race, color, religion, sex (including pregnancy, childbirth, or
related medical conditions), sexual orientation, gender identity or
expression, age, disability, national origin, marital or
domestic/civil partnership status, genetic information, citizenship
status, uniformed service member or veteran status, or any other
characteristic protected by law. GenScript USA Inc./ProBio Inc.
maintains a drug-free workplace. Please note: Genscript USA
Inc./ProBio Inc. will only contact candidates through verified
application sources. GenScript/Probio does not request personal
information from candidates through individual email or any other
platform.
Keywords: GenScript, Philadelphia , Sr. Manager, Quality Operations, Science, Research & Development , Pennington, Pennsylvania
