Executive Director of Quality Systems
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal.
Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Executive Director of Quality Systems position offers an exciting opportunity to establish and execute a Quality Management Systems Program to comply with current FDA regulatory requirements and guidelines and aligned with Company and Quality System’s goals. The Director of Quality Systems has oversight for both Quality Assurance (QA) and Quality Control (QC) Units. This position will also be an integral collaborator and key member of the upper management team advocating and advising on all aspects of Quality to drive innovation and achieve Company goals.
Essential Duties and Responsibilities:
· Leading Quality oversight to ensure the Quality Management System is implemented and maintained to regulatory and internal policy compliance.
· Providing direction to QA and QC Manager’s to ensure programs and procedures are consistently followed and properly documented.
· Building and mentoring the Quality Assurance (QA) and Quality Control (QC) teams by ensuring career development is provided along with appropriate training.
· Establishing strategic objectives for QA and QC Units to meet regulatory and Company expectations and goals.
· Overseeing the Quality Assurance and Quality Control Units to ensure product manufacturing and testing and out of specification investigations are completed in a proactive and timely manner.
· Ensuring compliance to Quality Systems and managing the completion of QMS actions, deviations, investigations, root-cause analysis, CAPA, regulatory commitments, and audits.
· Providing Quality oversight of contract manufacture and service providers to ensure they meet Company and regulatory compliance expectations, including supplier qualification, auditing, and QA agreements.
· Working with the Regulatory Affairs Department in submitting submissions and supporting documents to the FDA Center for Biological Evaluation and Research (CBER) for investigating and licensure of biological products.
· Ensuring Quality Risk Assessments are completed as required and validation activities are completed to meet regulatory and Company expectations.
· Performing other related duties and assisting on other projects in quality departments or from other departments as needed based on Company needs.
Supervisory Responsibilities: Quality Assurance and Quality Control Unit Managers
· Five to ten years in a biopharmaceutical company
· Extensive working knowledge and experience in Quality Assurance and Quality Control
· Developed problem-solving and time management skills
· Demonstrated success managing highly-productive teams to meet goals
· Self-motivated and able to drive the progression of a successful Quality System
· Ability to perform in a fast-paced environment
· Exceptional organizational skills
· Ability to both lead and foster a collaborative team environment
Education, Experience and Certifications:
· Bachelor’s degree in biological sciences (chemistry, biotechnology, pharmacy, pharmaceutical technology)
· Master’s Degree in Quality/Regulatory Science, preferred but not required
· Certifications in Quality Management Systems or equivalent a plus (SQA, RAP, etc.)
· Management experience with ability to work constructively in a team to drive innovation while maintaining high Quality standards
Must have excellent communication and writing skills with proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook). Ability to effectively present information in one-on-one, small groups and meetings.
Utilizes established mathematical and scientific techniques to compile and analyze data.
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include use of microscopes, close vision, peripheral vision, and the ability to adjust focus.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.