QA Computer Compliance Manager

vor 3 Wochen

Basel, Schweiz Sobi Vollzeit

**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 need lifesaving treatments.

As a QA Computer Compliance Manager you will play a crucial role in maintaining and enhancing our Quality Management System. Global GxP Compliance & Quality Systems shall, define, develop, manage, and maintain the overall Sobi QMS.

As a QA Computer Compliance Manager at Sobi, you will be the primary contact between project teams and the Quality Assurance Department, ensuring the compliance of computerized systems within the company.

Job location is Stockholm or Basel.
- Define, develop, manage, and maintain the overall Sobi QMS to meet cGxP requirements.
- Develop and monitor quality systems for computer compliance, including designing standards and SOPs for the computerized system lifecycle.
- Review and QA approve quality documentation such as SOPs, specifications, validation/qualification documents, and more.
- Lead internal and external audits/inspections related to computer compliance.
- Conduct software supplier audits and monitor adherence to audit programs.
- Stay updated on regulatory requirements and advise on quality-related issues.

**Qualifications**
- University degree in chemistry, biology, and/or pharmacy.
- Experience in pharmaceutical manufacturing, research, and development.
- Good knowledge of FDA 21 CFR Part 11, Eudralex Volume 4 Annex 11, and GAMP.
- Proficiency in English.

**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 1,700 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

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