External Quality Operation Manager

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  • Basel
  • Unbefristet
  • Vollzeit
  • 1 Monat her
Company DescriptionStatistics 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.Job DescriptionAbout the roleAs External Quality Operation Manager (EQOM), you will play a central role in ensuring strong quality oversight of external manufacturing partners and supporting the reliable supply of high-quality medicines. Acting as the main quality interface with Contract Manufacturing Organizations (CMOs), you will collaborate closely with internal stakeholders across Sobi in a fast-moving, global environment.This is a hands-on role combining operational responsibility with continuous improvement. You will help ensure compliance, strengthen partnerships and contribute to developing efficient, future-ready ways of working.This position is a Hybrid role, based in our Global Hub in Basel, Switzerland reporting directly to Head of Global QA External Operations.Key Responsibilities
  • Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO)
  • Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Techincal Agreement, that they meet relevant CGMP regulatory requirement.
  • Support the release products by QP Delegate according to delegation documents, when necessary
  • Support the External Service Provider (CMO) Qualification
  • Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier
  • Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance
  • Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA. Assess the performance of the product and the process as per Sobi requirement
  • Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement
  • Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements
  • Support that Quality Audits of the CMO is performed according to Sobi requirement and the QTA
  • Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization
  • Lead or act as Quality representative in project related to CMO eg Tech Transfer, Launch
  • Assess and ensure CMO for Health Authorities (HAs) inspection readiness
  • Support HA inspections/audits of Sobi
  • Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy
  • Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally
QualificationsAbout youYou thrive in a dynamic, international environment where priorities evolve and collaboration is essential. You are proactive, flexible and comfortable taking ownership, with the ability to balance operational detail and a broader quality perspective.You enjoy building strong relationships, influencing external partners and working cross-functionally to find practical solutions. Open to change and new ways of working, you bring energy, structure and a continuous-improvement mindset - and you are motivated by the opportunity to make a real difference for patients.Key QualificationsRequired:
  • High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
  • More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
  • More than 1 years of managing external quality oversight of CMOs
  • Curriculum is requested for evaluating the batch release qualification requirement
  • Fluently spoken and written English
Desired:
  • More than 2 years of working in global operation environment with English as a main language
  • Proven experience of leading Quality KPI assessment and improvement at CMOs
  • Proven track record with FDA; EMEA or other Health Authorities
  • Strong understanding of risk assessment and risk management fundamentals / tools
Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!Additional InformationHow to applyWe 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 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 1,900 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 CultureAt 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.

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