Quality Systems Manager

Quality Systems Manager

Work Location: New Jersey

Employment Status: Full time, on site

Reports to: Sr. QA Manager

About the company

Part of a large international group, that are a growing company who provide end-to-end CDMO services, from drug discovery to commercialization, in cell & gene therapy (CGT), vaccines, biologics discovery and more, to accelerate drug development for customers.

Their total cell and gene therapy solution covers CMC of plasmid and virus for IND filing, as well as clinical and commercial manufacturing. They have the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines, and has supported several mRNA vaccine global enterprises to obtain clinical approvals. They also have a stable and high-yield viral vector platform.

About the Position

The position reports to the Sr. QA Manager and is ideally suited for someone with background in implementation and execution of quality systems for CGMP production of drug substance and drug product. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities, to deliver products to the client projects that transform the lives of patients.

Responsibilities

• Quality systems setup, execution, maintenance and continuous improvement. This will include transfer to a new electronic system.
• Compliance and operation of core quality systems, such as change control, deviations, CAPA and OOS.
• Compliance and operation of other quality systems including quality trend review and raw material management.
• Understanding of the concepts and practices of phase appropriate compliance guidelines.
• Facilitating the interaction and connectivity between quality systems and validation/qualification programs, including facility, equipment and computer software validation.
• Contribute to other QA and cross-functional projects, as and when required.

Qualifications/Experinece

• Degree in a life science or related field.
• Several years of relevant professional experience, namely in drug/biologics quality assurance.
• Strong background in US FDA/EMA compliance requirements for CGMP production for Drug Substance and Drug Products.
• Familiarity with bio-processing, including cell banking, fermentation, purification, fill and finish will be highly advantageous, as would experience in QC or Production.
• Excellent communication skills, with the ability to lead and influence by example, as well as working independently.