ThermoGenesis, a wholly owned subsidiary of Cesca Therapeutics, is a pioneer and market leader in the development and commercialization of automated technologies for cell-based therapeutics and bio-processing. We’re dedicated to advancing technologies and improving lives.
POSITION: Quality Manager
POSTING DATE: February 7, 2019
Responsibilities and Duties
- Design, develop, implement, and manage a quality system to ensure compliance with the applicable ISO, EN, MDD, Canadian, and FDA/QSR quality system regulations.
- Facilitate a continuous quality improvement program that allows the organization to establish and reflect a high quality corporate image for customers, suppliers, and regulatory agencies.
- Provide recommendations and guidance to leadership and development teams in support of quality objectives.
- Oversee and manage quality assurance and quality control processes and staff.
- Establish, monitor and maintain an effective quality system to enable compliance with the FDA Quality System Regulation, and applicable ISO, EN, MDD, and Canadian, and other applicable regulations.
- Provide product development team and leadership product development guidance in order to meet product quality expectations.
- Write, review, and approve documents related to quality and regulatory (GMP) compliance. Provide guidance to product development teams in protocol development in support of meeting quality requirements.
- Facilitate the establishment of high quality and compliant corporate image.
- Provide guidance to all levels of the organization on matters of Quality including period reviews of the functioning of the Quality System to executive management.
- Serve as the primary contact during facility inspections and audits.
- Establish and maintain processes for measuring and monitoring product quality and quality system processes for providing feedback and assuring continual improvement.
- Manage QA/QC departmental budgets.
- Manage QC and QA staff.
Qualifications and Skills
- A Bachelor’s degree in sciences or a related field, or equivalent combination of demonstrated education, training and experience.
- Extensive auditing/surveillance experience and training in the Biotech industry.
- Quality related skills and training in relation to communication skills, root cause analysis, and risk assessment, conduct of operations, ISO standards and other applicable experience and education.
- Experience in quality assurance field within auditing, engineering, as well as inspection, testing etc. (preferred).
- Demonstrated ability in verbal and written English language.
If you are interested and meet these qualifications, please write a cover letter to officially apply for the new position. The cover letter should clearly explain your interest in the job and delineate how you are qualified for the job. Email letter along with resume to Human Resources at email@example.com.
ThermoGenesis is an Equal Opportunity Employer. If you are interested and meet these qualifications, please forward your resume to Human Resources at firstname.lastname@example.org.