Gxp E-compliance Manager

vor 2 Wochen

Basel, Schweiz Sobi Vollzeit

Full-time

Sobi Location: Switzerland

**Company Description**:
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.

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 here back from us.

**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-oriente

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