QA Analytical Specialist Lead

Job title:

QA Analytical Specialist Lead

Company

Sobi

Job description

Company DescriptionStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people.Are you ready to make a difference in the world of rare disease patients? At Sobi, we believe in harnessing the unique talents of individuals to create innovative therapies that change lives.Job DescriptionWe are seeking a QA Analytical Specialist (QAAS) QA Lead to take ownership of quality assurance for analytical activities and stability studies. You will lead the QA oversight for analytical methods supporting clinical and commercial use, ensuring compliance with GMP guidelines, regulatory requirements, and Sobi’s high standards. This pivotal role involves approving product specifications, managing Quality Technical Agreements (QTAs) with Contract Laboratory Organizations (CLOs), and providing strategic QA support across departments and complex projects.Key Responsibilities

• Act as GMP specialist for analytical activities, including stability studies.
• Ensure correct implementation of GMP guidelines in QA Analytics processes.
• Approve deviations, CAPAs, change controls, and manage internal QA investigations.
• Oversee analytical method validations, tech transfers, and stability studies.
• Liaise with Global Regulatory Affairs/CMC on analytical quality issues.
• Author, review, and approve SOPs and related documentation.

QualificationsYou are an independent and proactive professional with a natural ability to take initiative and drive tasks forward. Your strong communication skills allow you to collaborate effectively across teams and with external stakeholders. A dedicated team player, you thrive in a collaborative environment and consistently align your work with Sobi’s CARE values.Qualifications

• University degree (min. 4 years) in Chemistry, Biology, Biotechnology, or related field.
• 10+ years of QA experience in analytical science within a GMP environment.
• Strong understanding of regulatory guidelines, method validation, and product specifications.
• Proven experience managing deviations, CAPAs, and interactions with external stakeholders.
• Broad knowledge of analytical chemistry and bioassays.
• Fluent in English (written and spoken).

Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!Additional InformationHow to apply
At Sobi, we value work-life balance and due to the holidays, it may take a little bit longer until you hear back from us.
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.Why Join Us?
Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation for your work
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Sobi is a global company with over 1,800 employees in more than 30 countries and are committed to the societies where we operate. We are a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases, providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi’s share is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.Sobi CultureAt Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

Expected salary

Location

Stockholm

Job date

Sun, 22 Dec 2024 08:03:54 GMT

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