Head of Quality Assurance
Do you have a genuine passion for quality, a strong sense of accountability, and a keen eye for detail? Apply for the Head of Quality Assurance (QA) position at Biolamina and join us on our journey!
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 cross-functional groups and daily prioritizations alongside production and the supply chain organizations. This role requires a hands-on 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 market-leading 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 in-house 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 BioLamina's products meet release specifications.
- Collaborating cross-functionally 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 time-management abilities.
- Ability to work under pressure and manage multiple priorities.
- Proactive, with a hands-on 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 (HSLF-FS 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 problem-solving 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 close-knit 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 company's 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: http://www.biolamina.com
- Department
- Quality
- Locations
- Sundbyberg
Sundbyberg
Perks & Benefits
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A secure employment and benefits from the collective agreement
Occupational pension, work-related accident insurance,
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Parental leave compensation
Approx. 10 percent of the employee´s monthly salary
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Health and wellness initiatives
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Newly renovated premises in great location and equal ergonomic workstations.
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Working time reduction
Workplace and culture
“Working together, building on each other’s ideas and knowledge, creates greatness. I am proud that we are unpretentious, curious, and fearless enough to dare to approach and talk to people often more talented than we to build new partnerships. These abilities have helped us to find new ways forward through collaborations.”
Therése Kallur, PhD
CSO, VP Business Development
About BioLamina AB
BioLamina in Sundbyberg is a Swedish biotech company serving clients within research, biotech, and pharma globally. BioLamina produces and develops premium laminins, which are proteins used in e.g., stem-cell research and cell therapy development. We are a growing team, working within production, R&D, quality, sales and marketing, and customer service. The company has a certified quality system according to ISO 9001:2015. We pride ourselves on being a sociable and inclusive workplace, and we are now searching for someone who will continue to embed our strong positive employee culture and values.
Head of Quality Assurance
Do you have a genuine passion for quality, a strong sense of accountability, and a keen eye for detail? Apply for the Head of Quality Assurance (QA) position at Biolamina and join us on our journey!
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