Quality Assurance Operations Lead
Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.
We are excited for our next QA Lead to join the Viralgen team!
About the role
The holder of this position is a key member of the local management team and plays a major role in the overall management of the site and will lead the Quality Assurance Operations department and will report to the Quality Assurance Operations Director. In this context he/she is especially responsible for:
- Continuous improvement of Key Quality Indicators of company
- Lead inspections from regulatory agencies and customer related audits.
- Contact point for GxP departments for deviations, change control and CAPA management derived from production.
- Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
- Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.
- Participate actively in the digitalization roadmap of company
- Develops and implements quality standard operating procedures.
- Collaborate in daily activities of department such as, deviation and change management.
- Interact with regulatory agencies during inspections
- Collaborates with customers during product lifecycle.
Education and Experience
- Bachelor’s degree in Biochemistry, Biology, Chemistry, Pharmacy or related industrial, scientific, or business field required.
- > 5 years of related experience in pharma industry leading quality teams.
- Working for an international company with international standards.
- Knowledge on biological process (i.e., mAbs or Gene Therapy processes) is a plus.
- Knowledge on aseptic drug product manufacturing is a plus.
- Excellent verbal and written communication skills with the ability to train staff.
- Country language and English fluent as a must (presenting, writing, reading).
- Thorough understanding of manufacturing and production in the industry.
- Excellent organizational skills and attention to detail.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills.
- Very high social competence with persuasiveness and self-confidence, high level of energy and positivity based on a sincere personality.
- Team Player with a strong drive to create positive work environment, able to motivate and empower employees.
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