Head of Quality

BioLamina is seeking an experienced and knowledgeable Head of Quality to join our team. In this pivotal role you will lead the Quality Department overseeing all aspects of Quality Assurance (QA) Quality Control (QC) and the Quality Management System (QMS). As a key member of the management team this position is based at our headquarters in Sundbyberg Stockholm.

BioLamina is a rapidly growing and dynamic biotechnology company with a global reach. We offer a unique portfolio of products highly regarded within the international stem cell community and the expanding stem cell and cell therapy markets. Guided by our vision to become the worlds leading provider of cell culture solutions BioLamina is dedicated to enabling lifesaving therapies.

The Quality Department

The responsibility of the Quality department is to establish inhouse quality procedures standards specifications and systems and to support other departments to ensure operations within BioLamina meet the outlines of requirements. Quality Management at BioLamina is currently performed according to the ISO 9001:2015 standard.

QA department is responsible for the daytoday quality assurance of BioLamina products and activities. The department is responsible for maintaining and performing batch release processes supplier evaluations handling customer complaints change control management nonconformance and deviation management CAPA and other processes as defined in the QMS.

QC department is responsible for performing QC testing according to specification to verify the quality of bulk and finished products to design and validate methods to plan and perform stability studies to issue specifications for finished products and cell banks and other processes as defined in the QMS.

Key Responsibilities

As a member of the management team you will hold primary responsibility for the Quality Management System (QMS) and its compliance with ISO 9001 as delegated by the CEO. This includes leading quality discussions with customers partners and internal stakeholders. You will oversee the annual planning and execution of BioLaminas supplier evaluation and audit program as well as manage the budget and personnel planning for the Quality department.

In your leadership role you will conduct annual performance development and salary reviews for department employees while also ensuring a safe and supportive work environment for your team. Your work will align with the BioLamina Quality Management System and you will actively contribute to its continuous improvement. Additionally you will serve as the system owner and Admin User for Qualio and DocuSign.

Main Tasks

• Lead the Quality Department: Oversee Quality Assurance and Quality Control functions ensuring seamless operations and alignment with organizational goals.
• Enhance the QMS: Continuously develop and optimize the Quality Management System to support effective and efficient quality operations.
• Drive CrossFunctional Collaboration: Lead qualityfocused initiatives and actively participate in crossdepartmental projects and meetings as the QA representative.
• Ensure Compliance: Uphold regulatory and customer requirements for BioLaminas products and services ensuring adherence to industry standards.
• Provide Expert Guidance: Offer expertise in quality documentation and standards compliance contributing to the organizations knowledge base.
• Facilitate Training: Review approve and deliver qualityrelated training and guidance to BioLamina personnel to foster professional growth and compliance.
• Audit Management: Plan organize and host internal and external audits to ensure operational excellence and regulatory adherence.
• Supplier Oversight: Conduct thorough supplier evaluations and audits delivering actionable reports to maintain high standards in the supply chain.
• Cultivate Quality Culture: Promote and nurture a strong quality culture across the organization by fostering collaboration and cooperation with all departments.

Requirements

• Masters degree in a relevant natural science field.
• A minimum of 10 years of progressive leadership experience in quality management overseeing the full spectrum of quality functions within the reagents or pharmaceutical industries.
• Comprehensive knowledge of Quality Management Systems (QMS) Quality Assurance (QA) Quality Control (QC) as well as relevant policies regulations and legal requirements.
• Demonstrated success in leading and developing highperforming quality teams coupled with strong strategic thinking abilities and a proven track record of influencing and collaborating with senior leadership.
• Exceptional communication and relationshipbuilding skills enabling effective interaction across all levels of an organization.

Personal Skills

At BioLamina our core values shape our culture drive the companys mission and define the individuals who thrive here. We seek people who are aligned with these values as they serve as our moral compass and guide how we work together. The ideal candidate will embody the following qualities:

Respect for Knowledge: You value expertise and continuous learning demonstrating intellectual curiosity and an appreciation for scientific rigor. You are open to both sharing your knowledge and learning from others fostering a collaborative environment where everyone can grow.

Exploration of New Possibilities: You are innovative and forwardthinking with a desire to challenge the status quo. You are motivated to explore uncharted territory think creatively and take initiative in discovering new solutions. Your curiosity drives progress and helps push the boundaries of whats possible.

Collaborative Mindset: You thrive in a teamoriented environment believing in the power of working together to achieve common goals. You respect diverse perspectives are open to new ideas and enjoy collaborating with colleagues across disciplines to drive success for both the company and its mission.

BioLamina

At BioLamina youll be part of an international valuedriven organization working alongside dedicated and highperforming colleagues. We believe our products can change the world and we have high ambitions to do so. BioLamina is a learning organization and we do this from each other and from the outside. We value our employees and we are committed to ensuring that the work environment is pleasant sustainable and safe.

We pride ourselves in providing an equal workspace making sure people are given equal opportunities equal pay and are well accepted for their differences. Furthermore we embrace diversity and inclusion in all aspects of our business.

BioLamina AB is a Swedish biotech company founded on scientific innovations at Karolinska Institutet. Our main products are recombinant laminins human proteins used to maintain and expand pluripotent stem cells and other primary cell types for subsequent differentiation into specialized cell types. BioLamina is revolutionizing cell culture and our products are used by researchers worldwide to develop cellular therapies and contribute to the era of regenerative medicine. For more information please visit: