QA Analytical Specialist Lead

We 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 Sobis 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.

Qualifications :

You 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 Sobis 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 Information :

How to apply
At Sobi we value worklife 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 teamoriented environment
    Opportunities for professional growth
    Diversity and Inclusion
    Competitive compensation for your work
    Making a positive impact to help ultrarare disease patients who are in need of life saving treatments

Sobi is a global company with over 1800 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. Sobis 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 Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed firsthand 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 groundbreaking 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 cant 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.
 

Remote Work :

No

Employment Type :

Fulltime