Senior Technical Manager, Quality Assurance
Just is seeking a highly-motivated Technical Manager within the Quality group that desires to be part of a team focused on improving worldwide access to Biotherapeutics by supporting GMP plant operations. This individual will join the Quality team at Just with their primary responsibility being the building and enhancing the quality assurance systems along with supporting day-to-day QA responsibilities for GMP manufacturing. The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment are essential to be successful in this position.
- Oversee and develop the Change Control, Equipment commissioning and qualification, and document management quality programs.
- Develop and improve the Quality Risk Management program, including facilitating data-driven risk assessments and risk reviews, by combining technical and compliance-based rationale to drive procedures.
- Support the GMP training program to ensure compliance with early clinical GMP manufacturing.
- Drive the maturation of the NC/CAPA program and collaborate with manufacturing to determine cause, corrective action, and impact for deviations.
- Oversee Just's equipment management program to ensure manufacturing equipment is in a state of control, including reviewing and approving equipment calibration and preventative maintenance documents.
- Provide Quality oversight to quality risk management documentation and equipment facilities utilities qualification for a process transfer from development to Phase I/II clinical drug substance manufacturing.
- Mentor manufacturing and development groups in qualification/validation technical aspects, and compliance requirements.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.
Qualifications and Educational Requirements
- Bachelor's degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
- 8 - 10+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.
- Experience in technology and/or process transfer for late state clinical manufacturing or commercial qualification drug substance campaigns; commercial campaign support is a plus.
- Involvement with both technical and quality aspects of biologics manufacturing.
- Knowledge and expertise to solve complex technical problems.
- Significant experience navigating and managing various modules in a Quality Management System software suite.
- Excellent verbal and written communication skills.
- Strong focus on quality and attention to detail.
- Possess effective task/time management organization skills
- Capacity to develop solutions to technical issues of moderate to complex scope.
- GMP and compliance knowledge and experience with equipment qualification and validation in a cGMP manufacturing setting
- Previous experience working in upstream and/or downstream drug substance manufacturing
Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019. Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation. Learn more at www.just.bio