External Quality Operations Manager

Sobi - Swedish Orphan Biovitrum AB (publ); Stockholms kommun; Híbrido; SEK 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Opportunities for professional growth

Competitive compensation

Diversity and Inclusion

Flexible workplace for work-life

Descripción de la vacante

Sobi is seeking an External Quality Operation Manager (EQOM) to be the main quality contact for CMOs and oversee externally manufactured products. The role includes acting as a QP delegate with delegated batch-release activities for the EU market, in line with EU GMP Annex 16 and company procedures.

The position is a hybrid role located at our Global Hub in Basel, Switzerland or Stockholm, Sweden, reporting to the Associate Director, External Quality Operations.

Formación

• Degree in pharmacy/medicine/veterinary/chemistry/biology meeting national requirements.
• More than five years in pharmaceuticals/biotech QA or GMP/GDP areas.
• Over one year of external quality oversight of CMOs.
• Ability to provide degree certificates and transcripts for eligibility.
• Fluent written and spoken English.

Responsabilidades

• Lead quality oversight of CMOs ensuring GMP/GDP compliance.
• Act as a QP delegate for EU batch release with delegated tasks.
• Support CMO qualification and maintain QTAs defining responsibilities.
• Manage deviations, CAPAs, complaints and change requests with timely resolution.
• Review product quality and stability reports using KPIs for improvement.
• Support CMO audits and inspections readiness.
• Lead or represent Quality in tech transfers and quality transformations.

Conocimientos

Quality mindset

Cross-functional collaboration

English fluency

Educación

University degree in pharmacy/medicine/veterinary/chemistry/pharmaceutical chemistry and technology or biology

Descripción del empleo

Company Description

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.

Job Description

As External Quality Operation Manager (EQOM), you will be the main quality contact for our Contract Manufacturing Organizations (CMOs), building strong partnerships and overseeing the quality of externally manufactured products. Working with colleagues across Sobi, you will connect day-to-day quality decisions with our commitment to reliable supply.

You will combine hands-on quality operations with opportunities to improve how we work with external partners. The role includes acting as a Qualified Person (QP) delegate and carrying out delegated batch-release activities for the EU market, in line with documented delegation and applicable requirements. QP certification remains the responsibility of the certifying QP.

This position is a Hybrid role, based in our Global Hub in Basel Switzerland or Headquarter in Stockholm, Sweden reporting directly to the Associate Director, External Quality Operations.

Key Responsibilities

• Lead quality oversight of CMOs, ensuring manufacturing and distribution comply with Sobi’s quality system, QTAs and GMP/GDP requirements.
• Act as a QP delegate for EU batch release, reviewing batch documentation and completing delegated tasks under written delegation, Sobi procedures and EU GMP Annex 16; final certification remains with the certifying QP.
• Support CMO qualification and maintain QTAs that clearly define quality responsibilities.
• Manage deviations, CAPAs, complaints and change requests, ensuring timely resolution and escalation of critical and major quality issues.
• Review product quality and stability reports, using risk assessments and KPIs to guide remediation and continuous improvement.
• Support CMO audits, inspection readiness and health authority inspections and audits of Sobi.
• Lead or represent Quality in technology transfers, product launches and quality transformation initiatives, working closely with cross-functional teams.

Qualifications

You enjoy taking ownership and bringing clarity to complex quality questions. Comfortable moving between operational detail and the bigger picture, you approach changing priorities with structure, sound judgement and a practical mindset.

You build trust with colleagues and external partners, ask thoughtful questions and work collaboratively to find solutions without compromising quality. You welcome new ways of working and are motivated by seeing how your expertise can make a difference for patients.

Required

• A university degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology, or a recognised equivalent, meeting the educational requirements of Article 49 of Directive 2001/83/EC and applicable national rules. Eligibility depends on course duration and subject coverage, not the degree title alone.
• More than five years’ experience in pharmaceuticals or biotechnology, within quality assurance operations, production or another relevant GMP/GDP area, with practical experience appropriate to the delegated batch-release activities.
• More than one year’s experience managing external quality oversight of CMOs.
• Ability to provide degree certificates, academic transcripts and course descriptions for assessment of educational eligibility and suitability for Sobi’s QP delegate responsibilities. Appointment is subject to documented assessment, relevant training and applicable national requirements.
• Fluent written and spoken English, with the ability to communicate clearly with international colleagues and partners.

Desired

• More than two years’ experience in global operations, using English as the main working language.
• Experience using quality KPIs to assess CMO performance and deliver measurable improvements.
• Experience supporting inspections or working with the FDA, EMA or other health authorities.
• A strong understanding of quality risk assessment and risk management principles and tools.

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

Why Join Us?

We are differentiating ourselves through the passion of our people, the innovative products we bring to life, and the responsible business we operate.

To ensure that more patients benefit from our therapies now and in the future, and to align with the company’s ambitions for growth, we have five core values: Care, Ambition, Urgency, Ownership and Partnership.

Our Mission And Purpose Get Us Excited To Come To Work Every Day, But There Are a Few More Reasons To Join Our Team

• Opportunities for professional growth
• Competitive compensation for your work
• Diversity and Inclusion
• A flexible workplace that supports work-life balance

About Sobi

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases.

We are dedicated to capturing the scientific opportunities of our time. With our early roots in Sweden, we started as pioneers in Haemophilia. Today we are an innovate leader within rare diseases with a global reach.

• We are bringing brilliant ideas to life in rare disease areas with high unmet patient needs.
• We are experts on identifying breakthrough innovations, unlocking new therapies and levelling up global access to new treatments.
• Our global operational network and passionate team serve as the foundation for our success.

Sobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.