Vibalogics (https://vibalogics.com/) has partnered with HireMinds to identify top talent as they build out their Quality group at a new state-of-the-art facility in the suburbs outside Boston. They are based in Germany and are establishing a US site for late-stage development and commercial production of oncolytic virus, viral vector gene therapy, and viral vector vaccines. Led by a cell and gene therapy veteran as CEO, this role will be a critical hire in establishing the Quality organization as well as the corporate culture of the site with the goal of passing a Pre-Approval Inspection and to be able to deliver commercial supplies of viral products.
As a member of the Vibalogics Leadership Team the main function of this role is to lead all facets of Quality, including, but not limited to the functional areas of Quality Assurance, Quality Control, Quality Management Systems, and Regulatory for all of Vibalogics’s multi-site operations. This will include oversight of all Quality Control (in house and outsourced) testing, Microbiology, Environmental Management testing, Quality Assurance review and approval, Validation review and approval, GMP training, Compliance activities, Product Release activities, and interactions with regulatory agencies. This position is responsible for the overall meeting of business standards, achieving quality and compliance goals, and ensuring that Vibalogics is in full compliance with multi-jurisdictional government-mandated Quality and Regulatory policies and guidelines.
Director Quality Systems, Director Quality operations, Director QC and Regulatory team.
Responsibilities include but are not limited to;
• Collaborate with the Site and Department heads to ensure understanding and adherence to Quality Policies, Guidelines, Programs and Systems.
• Set standards for cGMP Quality in areas relevant to viral vector or viral vaccine manufacturing.
• Oversee testing and timely disposition of clinical and eventually commercial material.
• Ensure compliance of the raw material and consumables vendors against the Vibalogics standards.
• Submit and maintain Site Master Files with regulatory authorities for Vibalogics commercial facilities.
• Establish key performance indicators for management of the Quality function and create alignment of KPI’s with all Vibalogics facilities.
• Ensure the team is providing timely, accurate and complete reports on performance at monthly site management reviews and at the Quality Council.
• Develop operating and capital expense budgets for the Quality functions. Ensure timelines are met and costs remain within the established budget.
• Assessment of new opportunities and provide appropriate Quality and Regulatory input to prospective customers, including the demonstration of compliance through audit.
• Proactively develop and sustain strong relationships with top management of local/regional/national regulatory authorities, including design reviews prior to major capacity expansions as appropriate.
• Evaluate the functional strengths and developmental areas in the Quality organization and focus on continuous improvement to ensure that standards are met.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher in a life sciences or related discipline and 15+ years of industry experience in biologics and/or viral and gene therapy with 8-10+ years in a Quality leadership role. Vibalogics is seeking a Quality leader with a service oriented mindset to support client needs without compromising compliance needs as well as the ability to work in a highly entrepreneurial environment, making informed but quick decisions, driving results through hands-on implementation. Must have extensive knowledge of guidelines required by FDA, EMA, and other regulatory bodies and prior experience in creating, building, implementing processes, and managing multiple sites
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.