Head of QC - Vaccines
Posted on May 26, 2021 by Elevate Direct
Head of Quality Control
The Head of Quality Control (QC) is responsible for the oversight, management, and planning of QC labs to provide the highest quality of analytical support for vaccines manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations. The head of QC will provide leadership, evaluation, and training to all QC employees. The Head of QC will interact with internal and external partners, clients, and inspectors and maintains high quality standards and services.
Provide leadership for all aspect of QC Labs supporting commercial manufacturing.
Lead the QC Lab designs and set up.
Oversee the site vaccine QC daily operations.
Enhance current service offering and develop new capabilities.
Introduce new technologies & continuously improve operation excellence.
Continuously improve QC quality systems/documents, enhance QC data quality, and deliver high quality results.
Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment.
Ensure QC staff receive appropriate GMP training and maintain compliance and high-quality standards.
Recruit, train and retain a high-performance team to ensure best quality services.
Interact with external & internal customers to provide high quality services.
Maintain QC operating costs within budget.
As a site leadership team member, actively work with other SLT members to resolve the site issues and enhance the site quality/efficiency and collaboration across departments.
As a regional senior quality leadership team member,
Help regional quality & operation system improvements.
Enhance collaborations & knowledge/experiences sharing across client Biologics European sites
Provide support to other sites as needed.
Bachelor, Master, or PhD Degree in life science, engineering or related discipline
Candidate should possess strong and effective people management, problem solving and interpersonal skills and have a proven track record working cross-functionally across a wide variety of technical, business and operational areas.
Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.
Demonstrates good understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.
Minimum of 10-15 years of relevant pharmaceutical/biopharmaceutical/vaccine industry experience in CMC process development and/or GMP manufacturing.
Working knowledge and understanding of current regulations and industry trends for vaccines product development, manufacture and testing, including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.