GxP e-Compliance Manager
GxP e-Compliance Manager
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Job Description
As the GxP eCompliance Manager you will lead and manage the Computer System Validation (CSV) and ensure ecompliance of GxP systems. This role involves overseeing Quality Data Stewards evaluating and approving highlevel 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 highlevel quality concepts and documents and support Computerized System Validation (CSV) inspections and internal audits with followup 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 highperformance 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 crossfunctional 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 problemsolving abilities while keeping the big picture in mind and addressing issues with a sense of urgency.
Key Qualifications
- Bachelors 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 worklife balance and due to the holidays it may take a little bit longer until you here 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 teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
We are a global company with over 1800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday 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 firsthand 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 groundbreaking 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
