Site Quality Director
: Job Details :

Pacific International has been exclusively retained by a client in the biotechnology and cell solutions space. As the group grows steadily in the market, they have constructed a new site that is going to be defined as the model of manufacturing excellence and new ventures, and has been targeted as the key site to support their new CDMO partnership within bio-genesis.

With this, the leadership are ensuring that all functions and processes are effective from the very beginning; ensuring it becomes a fully functioning CDMO with impacting and state of the art resources, and locations of the highest quality. The are seeking a Site Quality Director, who would be a key player within this flagship facility. This professional would possess accountability for overseeing the quality validation and cultural standards, as well as ensuring the highest standard in material storage. They would ensure the effective time supply of consumables and components at a regional scale. Working closely with GMPs, they would also develop plans for product availability as well as efficiency and optimization within the product lines.

Job Responsibilities

• Drive impacting regional quality improvement across the region.
• Lead change management across quality that results in strategic delivery.
• Assess, create and improve CCS Quality Management System documentations, including complaints and change controls.
• Support operations by driving relationships with supplier and customer counterparts as the voice of quality and regulations.
• Develop and improve staff talent through education and mentorship.

Requirements and Skills

• Bachelor's Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
• Master's degree or higher preferred.
• 12 years of combined experience in quality management and regulatory affairs related to cGMP manufacturing, clinical trial manufacturing, and/or cellular therapies.
• Minimum 5 years of experience in a quality leadership role overseeing quality in a biologics, vaccine, or aseptic manufacturing environment.
• Experience providing quality management oversight in a cell therapy manufacturing environment is strongly preferred.
• Experience preparing and managing IND and/or BLA submissions to FDA preferred.

For further information, please contact ...@pacific-international.com, ...@pacific-international.com or ...@pacific-international.com.

At Pacific International, diversity, equity, and inclusion are at the core of who we are and what we do. Our commitment to these values is unwavering and we proudly champion diversity on behalf of our clients in every Executive Search mandate we undertake.

Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. In pursuit of these objectives, we actively encourage applications from individuals of all backgrounds and identities.