Quality Engineer and GxP e-Compliance Specialist

As the Quality Engineer and GxP e-Compliance Specialist you will play a pivotal role in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship. This role will support the company's vision of "Ensure eCompliance and Goes digital to enable Quality decisions driven by data" by overseeing GxP systems and its data processed in GMP, GDP, GCP, and GVP field and to ensure the lifecycle for appropriate governance and oversight. The specialist will also act as a business admin for Veeva QMS, SQM, and training modules.

The role reports to our GxP e-Compliance Manager.

Key Responsibilities

- Ensure eCompliance through comprehensive GxP system lifecycle management, including acting as Business Admin for GxP systems (i.e. Veeva QMS, SQM, and training modules.
- Drive the digital Quality roadmap and process quality automation across the GxP arena. Collaborate with cross-functional teams to identify opportunities for digital transformation and process improvements. Act as the business admin for Veeva QMS, SQM, and training modules. Ensure effective management and utilization of these systems to support quality and compliance objectives.
- Oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field. Ensure efficient collection, processing, display, and storage of data, making it readily available for Quality Management review to facilitate prompt decision-making and reporting to health authorities and partners during audits and inspections.
- Support the demands to maintain GxP learning processes and quality documentation processes, including owning procedural documents and global work instructions for GxP training, training matrix maintenance, and GxP governing documents. Supporting manage document training distribution via LMS and maintain an active organization for local training admins (QCTCs).
- Implement Sobi standards and verify compliance through periodic reviews. Ensure adherence to current GxP and Sobi requirements. Evaluate and support the approval process of quality documents and records within Veeva.
- Support CSV activities (observing the segregation of duties), inspections, internal audits, follow-up activities, and remediation guidance. Enable divisions and business units to implement global CSV standards. Represent Global QA for e-compliance standards within Sobi as a specialist
- Facilitate the streamlined integration of new companies and their GxP systems into our e-compliance framework by developing and implementing adaptive GxP processes, ensuring regulatory compliance, providing training to promote a culture of quality and compliance, overseeing the refinement and adaptation of GMP processes for quality management of development products, and ensuring efficient and compliant cross-functional change control processes.

We are seeking a detail-oriented professional to ensure eCompliance through robust GxP system management and data stewardship. Strong analytical skills are required to drive digital quality initiatives and identify process improvements. Effective communication is essential for cross-functional collaboration and supporting GxP documentation. The ideal candidate is proactive, ensuring compliance with Sobi standards through regular reviews, and adaptable, facilitating the integration of new GxP systems. Problem-solving skills are key for supporting CSV activities and audits. A commitment to quality and continuous improvement is vital for refining GMP processes and managing compliant change control.

Key Qualifications

- Documented education in Natural science, chemistry, pharmacology, pharmaceutical development, IT or corresponding work experience within IT and or the GxP area/areas. Advanced competency for use IT systems and office suite.
- Minimum of 5 years of experience in GxP compliance, quality assurance, or a related field within the pharmaceutical industry.
- Strong knowledge of GxP processes and computerized system validation (CSV) standards.
- Experience with digital quality systems and tools, including Veeva QMS, SQM, and training modules.
- Experience with digital transformation initiatives and process automation in the pharmaceutical industry.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluent in English (written and oral)

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

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.

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 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.