Company Description

Statistics 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, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description

About the role

As the Clinical Quality Manager, you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams. Acting as the single point of contact for external suppliers, you will oversee manufacturing quality, ensure adherence to GMP & GDP regulations, and build strong cross-functional relationships with internal stakeholders.

The role is located at the global Sobi HQ in Stockholm, Sweden or in Basel, Switzerland.

Key Responsibilities

• Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
• Maintain oversight of quality topics for Sobi IMPs across markets
• Continuously improve work processes related to quality and compliance of IMPs
• Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
• Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
• Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
• Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.
• Support supplier audits and ensure readiness for Health Authority GMP inspections.

Qualifications

About you

You are comfortable in a global and dynamic environment where priorities shift often and a highly diplomatic and tactful individual with excellent critical reasoning, risk-analysis, and problem-solving skills. Is it vital to have interpersonal and leadership skills with the ability to influence external suppliers and cross-functional teams to foster open and collaborative discussions around difficult decisions and impactful solutions.

Key Qualifications

• Bachelor’s degree or equivalent education/degree in life sciences.
• Have a solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
• Minimum (10) years of experience within pharmaceutical, biotech product.
• Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials
• Extensive experience in QA operation, production or other relevant area (GMP, GDP)
• Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM.
• Strong understanding of risk assessment and risk management fundamentals / tools
• Fluently spoken and written English

Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!

Additional Information

How to apply

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 Culture

At 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.