Sr. Manager, Quality Operations

Sr. Manager, Quality Operations

Pennington, New Jersey, United States

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.

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

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

Lead Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions:

• Develops procedures for and performs local batch disposition for Gene Therapy Drug Substance, Drug Product, MCB (Master Cell Bank), Plasmid and Finished goods manufactured at the Hopewell, NJ site.
• Issues batch compliance documentation such as Certificates of Conformance/ Compliance / Quality (CoCs/COQs), Certificates of Analysis (CoAs), BSE/TSE Statements.
• Develops and manages QA functions related to Cell Bank and Plasmid disposition, usage, and lifecycle.
• Oversees ProBio QA Area Release/ Line Clearance Procedures and facility walkthroughs.
• Oversees the QA approval of calibration reports for GMP equipment/instruments in Maximo
• Supports internal and external audits to assure compliance with GMP regulations.
• Manages or performs QA "person-in-plant" type activities during cell bank receipt, manufacturing, filling, labeling, visual inspection, packaging, warehousing and shipping activities.

Directs Document Control, Records Management & training activities for the Gene Therapy Manufacturing Site Activities. This may include, but may not be limited to the following functions:

• Oversees Document control activities related to approval of local electronic documents such as SOPs, Standards, Forms, Work Instructions, Master Batch Records, and specifications.
• Develops and implements local procedures for control of drug product label proofs, printed labels, and reconciliation of unused/damaged labels.
• Manage Veeva Vault administration for all Veeva Vault applications.
• Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems.
• Recommends Quality system changes to enhance overall job performance and Quality functions and partners with peers in overseeing the implementation of these changes.

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.

The Pay range is estimated between $110000 - $150000, based on experience and skill set