Sr. Manager, Quality Operations

About Gen Script
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 Pro Bio'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 Pro Bio'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.

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GenScript USA Inc/Pro Bio 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./Pro Bio Inc. maintains a drug-free workplace.

Please note:

Genscript USA Inc./Pro Bio 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.