About Us
We are a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines.
Our scientific expertise in understanding the underlying causes of genetic conditions enables us to create transformative medicines, using a number of treatment modalities.
We have developed our medicines for patients with significant unmet medical need.
We work collaboratively with talented individuals who possess the right technical expertise and a relentless drive to solve real problems.
About Our Technical Operations Team
Our Technical Operations group is responsible for creating our drugs for use in clinical trials and scaling production of those drugs for the commercial market.
These engineers, technicians, scientists, and support staff build and maintain our cutting-edge manufacturing processes and sites, provide quality assurance and quality control, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
QA Systems Specialist Role
The QA Systems Specialist works closely with internal and external stakeholders to enhance our quality systems and platforms, focusing on performance metrics and data, and sponsoring change for continuous improvement.
The specific goals of this role include:
* Enhancing quality metrics generation within the scope of our quality pillars.
* Supporting global alignment on quality metric initiatives.
* Developing appropriate platforms for each pillar to facilitate compliance with procedures and health authority requirements.
* Coordinating the Site Quality Review Team meeting.
* Supporting the compilation of relevant Annual Product Review memos.
* Assisting in developing supplier quality management and providing quality support in supplier investigations.
* Providing support for inspection-related activities.
* Training others in areas of expertise.
Requirements
This role requires working independently and within a team to meet established timelines, coordinating activities with others, and being ready to support or help others with change.
The ideal candidate will have:
* A strong ability to identify and escalate concerns or risks as appropriate.
* Accountability for delivering on commitments.
* Attention to detail and a customer-focused approach.
* An initiative and enthusiasm to deliver change.
* Strong written and verbal communication skills.
* Collaborative skills and a successful track record in achieving goals as part of a team.
* Proficiency in data analytics and visualization tools, such as Microsoft Teams, Power BI, and Veeva.