GxP e-Compliance Manager

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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 transforms 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

As the GxP e-Compliance Manager you will lead and manage the Computer System Validation (CSV) and ensure e-compliance of GxP systems. This role involves overseeing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits. The manager will also define and maintain corporate CSV standards and drive the digital Quality roadmap across the GxP arena.

You will have 5 direct reports located in Sweden and Switzerland. The role reports to our Head of Global GxP Compliance & Quality System, based in Basel, Switzerland.

Key Responsibilities

- Ensure eCompliance: Oversee GxP system lifecycle management, manage Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support Computerized System Validation (CSV) inspections and internal audits with follow-up activities and remediation guidance. Provide leadership in ensuring compliance and quality standards are met.
- CSV Standards and Implementation: Define, maintain, and serve as the single point of contact (SPOC) for corporate Computerized Systems Compliance (CSV) standards across the company. Enable divisions and business units to implement these global CSV standards. Lead the development and enforcement of these standards.
- Compliance Verification: Implement Sobi CSV standards and verify compliance through periodic reviews, ensuring adherence to current GxP and company requirements. Lead the compliance verification process to maintain high standards.
- Digital Quality Roadmap: Develop and drive the digital Quality roadmap and process quality automation across the GxP arena. Provide strategic leadership in the digital transformation of quality processes.
- Training and Guidance: Provide training and guidance to the team and other stakeholders on CSV standards and eCompliance requirements. Lead the development and delivery of training programs to ensure comprehensive understanding and adherence.
- Regulatory Monitoring: Monitor and analyze global regulatory updates related to GxP and integrate relevant regulatory requirements into the Quality Management System (QMS). Lead the integration of regulatory changes to maintain compliance.
- Continuous Improvement and Leadership: Lead initiatives to enhance GxP compliance processes. Engage with stakeholders to ensure alignment in GxP practices, focusing on the QA digital strategy. Develop and manage a high-performance team, fostering collaboration. Drive continuous improvement and innovation in compliance processes, and develop team skills to meet organizational goals and standards.

Qualifications

We are seeking an individual who demonstrates honesty, transparency, and strong ethical standards in all interactions, ensuring trustworthiness and ethical conduct. You inspire your team with collaborative leadership, fostering cross-functional cooperation and innovation. As we are an entrepreneurial company you adapt quickly to changing environments with resilience. Maintains a keen eye for detail, ensuring accuracy and thoroughness in compliance and quality activities. Possesses strong analytical and problem-solving abilities, while keeping the big picture in mind and addressing issues with a sense of urgency.

Key Qualifications

- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- Minimum 10 years of experience in the pharmaceutical industry within Quality systems, manufacturing, R&D, or regulatory affairs, with at least 4 years in a leadership role.
- Strong understanding of GxP regulations, including FDA, EMA, and other relevant requirements.
- Proven experience in GxP system lifecycle management, quality data stewardship, and defining/implementing CSV standards.
- Experience in digitalizing QMS, writing procedural documents, and developing digital quality roadmaps.
- Proficiency in performance management, KPIs, and Quality Management Review.

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

Additional Information

How to apply

At Sobi, we value work-life 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 and cover letter 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

We are a global company with over 1,800 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.

Seniority level

- Mid-Senior level

Employment type

- Full-time

Job function

- Quality Assurance
- Industries
- Pharmaceutical Manufacturing

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