External Quality Operation Manager Fixed-term maternity cover 12 months

About the role

As 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 highquality medicines. Acting as the main quality interface with Contract Manufacturing Organizations (CMOs) you will collaborate closely with internal stakeholders across Sobi in a fastmoving global environment.

This is a handson role combining operational responsibility with continuous improvement. You will help ensure compliance strengthen partnerships and contribute to developing efficient futureready ways of working.

This position is a Hybrid role based at our Headquarter in Stockholm Sweden 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

Qualifications :

About you

You 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 crossfunctionally to find practical solutions. Open to change and new ways of working you bring energy structure and a continuousimprovement mindset and you are motivated by the opportunity to make a real difference for patients.

Key Qualifications

Required:

• 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 Information :

How to apply

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 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 1900 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 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 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 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 :

Full-time