Quality Assurance (QA) Manager and Team Leader to BioLamina AB

BioLamina is looking to recruit a Quality Assurance (QA) Manager and Team Leader to join the Quality Department of the company.
In this new role at the company, you will lead the daily tasks for the departments QA Managers and have responsibility for the overall administration and development of the companys Quality Management System (QMS) together with the team. The Quality Management at BioLamina is today performed according to the ISO 9001:2015 standard, with the plan of achieving a GMP level production of some of our product lined in a couple of years.
You will be working with highly competent, friendly and dedicated colleagues at a company that is continuing its successful growth. If this sounds interesting to you - come join us!

The role is full time and based in Sundbyberg, Sweden. We will evaluate applications continuously and we welcome your application today!

About the position
The Quality Department at BioLamina is responsible for establishing in-house quality procedures, standards, specifications, systems, and to support other departments to ensure that the operations at BioLamina meet outlined requirements. As a QA Manager and Team Leader your main responsibilities will include:

- Lead the daily tasks for the departments QA Managers, helping with daily prioritizations
- Contribute to the continuous development of the QMS
- Review and approve documentation such as deviations, batch records, change control, CAPA, study reports and plans
- Ensure that BioLaminas products comply with release specifications
- Collaborate cross-functionally and provide QA support to other functions at the company
- Organize internal and external audits
- Provide quality training
- Participate in quality and regulatory discussions with external partners and customers.

Your profile
Key qualifications for the position include:
- M.Sc in pharmacy, biotechnology, chemical engineering or related field.
- Multiple years of experience from working in a QA-position (preferably within production of biotechnological products) and knowledge and understanding of regulatory requirements for GMP
- Experience or formal qualification as a Qualified Person (QP) is a strong plus
- Experience from team and project management is meritorious
- Excellent writing and communication skills in English

We are looking for someone with a passion for quality, a high sense of accountability and an eye for detail. We believe you to be a pro-active, organized and dependable person with strong interpersonal and collaborative skills. Excellent communication, problem-solving and administrative skills are necessary to be successful in this role.
Since we are a smaller organization of friendly, competent and helpful people, we rely on each other in our everyday work and together we work towards overall goals of the company.
We value our employees and their professional growth and we are committed to ensuring a stimulating work environment that is pleasant, sustainable and safe. We look forward to having you on this journey!

About the organisation
BioLamina AB is a Swedish based Biotech company that originates from scientific innovations at Karolinska Institute. Our main products are recombinant laminins, human proteins that are being used to maintain and expand pluripotent stem cells and other primary cell types and for subsequent differentiation into different specialized cell types. BioLamina is revolutionizing cell culture and our products are being used by researchers to develop cellular therapies, building on the era of regenerative medicine. Founded in 2009, BioLamina has grown organically and today we are about 45 employees who develop, produce, market, and sell cell culture research reagents to academic and industrial scientists globally. For more information, please see: http://www.biolamina.com

BioLamina is a member of IKEM - Innovation and Chemical Industries in Sweden. IKEM has collective agreements with relevant trade unions of the sector, and as a member Biolamina is fulfilling terms of employment according to collective agreement.

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