Senior Clinical Quality Assurance Specialist

The BioInvent team covers all parts for drug development, including preclinical research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as our Senior Clinical Quality Assurance Specialist.


Key Responsibilities
As a Senior Clinical Quality Assurance Specialist, you will be part of our QA team that is responsible for a Quality Management System for GCP and GMP.
Your responsibilities will be:
Improvement and maintenance of our clinical Quality Management System (cQMS).
Participate and conduct trial related audits, e.g. of vendors, investigational sites and internally in system and trial audits.
QA representative and provide support to clinical functions in key QMS processes, e.g. vendor selection, qualification and oversight, Change Controls, GCP and protocol deviations, CAPAs and SOPs.
Manage the clinical QMS activities and prepare status reports at Management review meetings.
Support preparation and hosting of regulatory inspections.
Support internal training on cQMS and ICH-GCP.
Interface with GMP QA e.g. in relation to BioInvent´s electronic document management system, deviation investigations, mock recalls and product complaints.
Ensure to attend and receive continuous training in relevant clinical and quality regulations and guidelines.

Requirements
In-depth knowledge of ICH-GCP
Experience in auditing (internal, external) highly desirable
Excellent verbal and written communication skills
Very good organization skills
Strong analytical and problem-solving skills
Self-motivation and independent
Efficient, risk based and solution-oriented mindset, multi-tasking, quick learner, respond to urgent needs of the team and show a strong track record of meeting deadlines.
Nurture a culture of teamwork, positive team spirit, promoting the development of each member in the team.
Knowledge and understanding of the importance of creating efficient working environment and contributing to ensure continuous improvements. Able to deal with frequent change, delays, or unexpected events.
Perform all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.
Knowledge and understanding of the overall BioInvent´s key objectives and well versed in the company structure and other departments.

Qualifications:
University degree in natural sciences/engineering/quality management
At least 3 years´ experience in the biotech or pharmaceutical industry in a GCP compliant environment.

Location
The position is office based in Lund. However, the position may also offer a flexible working arrangement.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/ Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-06-13.


BioInvent has a collective agreement and contact persons for the Unions are: Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben