(Senior) GxP Quality System Manager

The Senior GxP Quality System Manager is responsible for maintaining and improving Sobis 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 :

• Bachelors 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 Sobis 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 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.

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.

Remote Work :

No

Employment Type :

Full-time