(Senior) GxP Quality System Manager

JobsCloseBy Editorial Insights

A Senior GxP Quality System Manager role at Sobi in Basel offers a hands on opportunity to lead the ongoing development and agile evolution of the Quality Management System, align it with the Global Quality Mission, and drive adoption of QMS changes across functions and affiliates. You will oversee Document Change Control, propel continual improvement for regulatory compliance, develop clear quality communications, support inspection readiness, and collaborate with GPOs on process standardization and training. Ideal candidates hold a Bachelor’s in Life Sciences or related field with 3 to 5 years in pharma quality systems, proven QMS experience, strong KPI and Quality Management Review skills, and international exposure; fluent English with leadership and problem solving. To apply, tailor your CV to show measurable QMS improvements, concrete change initiatives, and demonstrate alignment with Sobi values Care Ambition Urgency Ownership and Partnership, plus readiness to work onsite in Basel.

Company Description

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 people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

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:

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

Job Description

The Senior GxP Quality System Manager is responsible for maintaining and improving Sobi's Quality Management System (QMS). Main responsibilities include:

• Lead the development and continuous improvement of an agile QMS framework aligned with company strategy and Global Quality Mission.
• Manage QMS changes, assessing impact and ensuring effective adoption across functions and affiliates.
• Oversee the Document Change Control process and global/local process alignment across GxP areas.
• Lead continual improvement activities to ensure regulatory compliance and strengthen QMS performance.
• Develop and deploy effective quality-related communication within the organization.
• Support inspection readiness and provide guidance on closing regulatory compliance gaps.
• Collaborate with GPOs on process standardization, training strategies, and keeping them updated on QMS changes.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field, with minimum 3-5 years' experience in pharmaceutical industry Quality Systems, manufacturing, or R&D
• Proven experience in Quality Management Systems, processes, and procedural document writing
• Demonstrated ability in performance management, KPIs, and Quality Management Review
• Experience working in an international organization
• Fluent in English with strong leadership and communication skills
• Proactive mindset with excellent problem-solving and interpersonal skills
• Ability to navigate complex situations, handle conflicts, and create win-win outcomes
• Cultural awareness and understanding of diverse work environments
• Holistic business understanding with courage, empathy, and trust-building capabilities

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

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 up 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.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.