Quality Assurance (QA) Manager to BioArctic AB

BioArctic is now recruiting a Quality Assurance (QA) Manager to the company. The position is full-time and based in our headquartered office in Stockholm and we are reaching out to find a new colleague to join a dedicated and highly competent team within the QA department.

As a QA Manager, you will play a crucial role in providing quality oversight of biopharmaceutical development activities outsourced to CMOs and CROs and the supply of investigational medicinal products to clinical trials. You will apply your experience and expertise within QA to ensure GMP compliance and collaborate with colleagues within the QA department and cross-functionally with internal and external stakeholders. This is an excellent opportunity for you to join a great company with an exciting journey ahead. If this sounds interesting to you – Come join us and contribute to our mission of improving the lives of patients with neurodegenerative diseases.

We will interview candidates continuously and welcome your application today!

Responsibilities

As a QA Manager, you will report directly to the Senior Director Quality Assurance at BioArctic.
Your main responsibilities will include:
– Assess and approve batch related documentation such as specifications, batch records, deviations and change requests.
– Ensure that production and testing of clinical trial materials are conducted according to GMP and the requirements of the IND/IMPD.
– Monitor and maintain the Quality Management System. Review and approve SOPs, periodic review and supplier re-evaluation.
– Lead and participate in self-inspections and audits of service providers.
– Represent QA in cross-functional project teams.
– Provide support and guidance to the organization in quality issues.
– Perform internal GxP training.
– Contribute to key strategic developments within the QA department.

Your profile

Key Qualifications for the position include:
– MSc in Pharmacy, Biology, Chemistry or Engineering.
– Significant experience of working within GMP regulated pharmaceutical industry in development of biopharmaceuticals.
– Experience from development and manufacturing activities for biopharmaceuticals.
– Several years of experience from a QA organization.
– Experience from managing quality processes such as deviations, CAPAs, change requests and vendor assurance.
– Understanding of the drug development process and supply chain process.
– QP/RP experience is an advantage.
– Good scientific understanding of biological drugs (products and process).
– In-depth understanding of Quality Systems and GMP legislation and guidelines.
– Good knowledge of national and EU GDP.
– Fluent in Swedish and English.

We are looking for someone with a can-do attitude, strong organizational skills and a quality-driven mindset. You work well both independently and in team settings and can handle multiple tasks and manage priorities in a timely manner. You enjoy taking responsibility and initiative as well as sharing your expertise with others and have excellent collaboration and communication skills. You are analytical, result-oriented and can effectively make decisions using risk management and independent judgement. Importantly, you enjoy a dynamic place of work where people matter and your contributions will make a positive impact.
If you are passionate about making a difference in the lives of patients with neurodegenerative diseases and have the skills and experience to excel in this role, we invite you to apply today!

About the organisation

BioArctic AB (publ) is a research-intensive biopharmaceutical company that, together with its partner Eisai, has developed Leqembi® (lecanemab) – the world’s first drug to slow the progression of the disease and reduce cognitive impairment in early Alzheimer’s disease. In addition to royalties on global sales, BioArctic has the right to commercialize lecanemab in the Nordic market together with Eisai. BioArctic has a broad research portfolio with antibodies against neurodegenerative diseases such as Parkinson’s disease and ALS as well as additional projects against Alzheimer’s disease. A Phase 2a clinical trial of BioArctic’s most advanced antibody for the treatment of Parkinson’s disease, exidavnemab, is expected to be initiated in 2024. Several of the projects utilize the company’s proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic’s B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.se.