Head of Quality Assurance

BioLamina is seeking a Head of Quality Assurance (QA) to join our Quality Department. In this pivotal position you will lead the daily operations of the QA Managers ensuring the timely and effective execution of quality assurance tasks. Your responsibilities will include overseeing product release change management CAPA quality risk assessments and active participation in crossfunctional groups and daily prioritizations alongside production and the supply chain organizations. This role requires a handson approach serving as the knowledge hub of the team and contributing at an operational level when necessary.

Currently BioLamina operates under the ISO 9001:2015 standard for its Quality Management System with plans to advance certain product lines to GMP level production in the coming years. BioLamina is producing marketleading cell culture matrices for the academic research and the cell therapeutical market.

Join our dynamic team of collaborative professionals in a company poised for continued growth. If this opportunity aligns with your expertise and aspirations we invite you to apply and be part of our journey!

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 tasked with establishing inhouse quality procedures standards specifications and systems to ensure compliance with outlined requirements. As the Head of QA your primary responsibilities will include:

• Leading and developing members of the QA Operations team (currently 5 FTE) including hiring performance management bonus evaluation and salary reviews.
• Managing the budget for the QA department.
• Contributing to the continuous improvement of the Quality Management System (QMS).
• Write review and approve documentation such as deviations batch records change controls CAPA risk assessments study reports and plans.
• Ensuring BioLaminas products meet release specifications.
• Collaborating crossfunctionally and providing proactive QA support to other departments.
• Organizing internal and external audits.
• Planning and performing supplier evaluation of suppliers of consumables starting materials and services.
• Reviewing Quality questionnaires and quality agreements
• Providing quality training
• Participating in quality and regulatory discussions with external partners and customers.
• Lead mentor and develop the operational team to achieve high performance and meet organizational objectives.
• Collaborate with senior management to align operational activities with strategic goals.

Your profile should ideally include the following qualifications

• A Master of Science degree in pharmacy biotechnology chemical engineering or a related field.
• Several years of experience in a QA position preferably within aseptic manufacturing of large or small molecules under a GMP certificate.
• Expert knowledge of GMP regulatory requirements of aseptic manufacturing of large or small molecules or ISO20399:2022 Biotechnology ancillary materials present during the production of cellular therapeutic products and gene therapy products.
• Proven track record of improving operational processes and leading successful teams.
• Excellent communication leadership and interpersonal skills.
• Excellent organizational and timemanagement abilities.
• Ability to work under pressure and manage multiple priorities.
• Proactive with a handson approach to leadership.
• Ability to inspire and motivate teams to achieve high performance.
• Excellent writing and communication skills in English are required (equivalent to CEFR C1 level or higher).
• Experience or formal educational fulfillment as a Qualified Person (QP) is highly desirable (HSLFFS 2021:102 13).
• Ability to perform and coach statistical analysis is a strong plus.

We seek an individual with a genuine passion for quality a strong sense of accountability and a keen eye for detail. As someone who thrives on proactivity organization and reliability you should possess exceptional interpersonal and collaborative skills. Effective communication adept problemsolving abilities and strong administrative skills are essential for excelling in this role. Furthermore the ideal candidate should enjoy operating in an environment that is in continuous development as BioLamina is a company in strong growth.

Given our closeknit team environment comprised of friendly competent and supportive individuals we place great emphasis on mutual reliance in our daily endeavors as we collectively strive toward the companys overarching objectives.

At BioLamina we deeply value our employees and their professional development. We are dedicated to fostering a stimulating work environment that is not only pleasant and sustainable but also prioritizes safety. We eagerly anticipate welcoming you aboard this journey of growth and achievement!

About the organization

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 100 employees in Sweden and USA who develop produce market and sell cell culture research reagents to academic and industrial scientists globally. For more information please see: