At BioInvent we are experts on antibodies and cancer immunology. We strive to develop first-in-class immuno-modulatory antibody-based - treatments that have significant potential to improve cancer outcome and cancer patients’ quality of life. We are based in Lund in Sweden and amongst our 90+ employees cover all parts for drug development including preclinical research, process development and GMP production and clinical trials.
Together we are creating an exciting future for BioInvent and we welcome you to be part of this journey as our
The Compliance Specialist will report to the Director of Manufacturing and cover the compliance aspects of Quality Control and Manufacturing. This position will be the link between Manufacturing, Quality Control and Quality Assurance and have the responsibility of updating various GMP documents, compiling batch records, reviewing documentation, conducting investigations, handling changes /CAPA and validation.
In this position you will be required to serve as the representative on various projects that involve investigations and relevant compliance inquiries as well as participating in audits and inspections.
Other responsibilities in this role includes:
- Perform and lead initial review of investigations, regulatory inquiries, requests for information/documents, and other related inquiries due to issues identified.
- Identify individuals required to complete a detailed and complete investigation.
- Lead and conduct interviews of appropriate parties to acquire required facts, data and information as part of any special review or investigation.
- Analyze, investigate & develop written responses to verbal and written inquiries from regulators and internal business units.
- Prepare, review and consolidate reports of findings and present recommended actions to management and Quality Assurance.
- Compile batch records for GMP Manufacturing based on input from Process Development, Quality Control and Quality Assurance.
- Review completed batch documentation to ensure that documentation is accurate and reflective of the work performed.
- Lead development and maintenance of all department tracking data and preparation of dashboard/trend reporting.
- Attend meetings and present on topics relevant to the Compliance tasks.
We a looking for a person who has a Bachelor’s degree or higher. At least 5 years’ experience with GMP requirements is a must. Experience with Veeva Vault or another QMS is an advantage. Strong presentation skills are desired including experience in presenting issues/recommendations to Management and Quality Assurance. Knowledge of upstream and downstream processes is an advantage.
To succeed in this position, you need to be meticulous, intuitive, innovative, and be able to handle a high volume of work independently. You also need to have effective interpersonal communication skills with the ability to articulate concern(s), both in writing and verbally (English is used as our company language). We think you are a person who can analyze data and think through complex investigative and compliance issues together with an ability to prioritize workflow items and strong time management skills to meet timelines.
If you are the one we are looking for, please send in your application to us as soon as possible, or by the 13th of December the latest.
BioInvent has a collective agreement and contact persons for the Unions are Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben