Internal Quality Operations Manager at Sobi

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

29 Mar, 26

Salary

0.0

Posted On

29 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, GMP, GDP, Pharmaceutical Operations, Cross-Functional Collaboration, Continuous Improvement, Regulatory Compliance, Health Authority Inspections, Deviation Management, CAPA Management, Product Release, Digitalization Initiatives, Stakeholder Communication, Quality KPIs, Problem Solving, Team Collaboration

Industry

Pharmaceutical Manufacturing

Description

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 About the role As Internal Quality Operations Manager (IQOM), you will be responsible for the quality oversight of Sobi’s internal GMP and GDP activities, ensuring that manufacturing, distribution and product release are performed in full compliance with regulatory requirements. You will act as the central quality contact for internal operations, safeguarding product quality, supporting timely product release as a QP Delegate, and driving improvements across quality processes. You will collaborate closely with Global Quality Operations and cross-functional teams to manage quality events, support Health Authority inspections, and lead or contribute to quality improvement and digitalization initiatives. Your work will be critical in ensuring that Sobi continues to deliver safe, compliant medicines while supporting the company’s continued growth. This position is a Hybrid role, based at our Global Headquarters in Stockholm, Sweden, reporting directly to Head of Global QA External Operations. Key Responsibilities Act as the single point of contact for internal quality-related activities within Sobi Perform product release activities as a QP Delegate in line with delegation and regulatory requirements Drive remediation plans and continuous improvement initiatives to strengthen quality performance Manage and approve deviations, CAPAs and complaints in accordance with Sobi procedures Represent Quality in cross-functional and digitalization projects Support Health Authority inspections and ensure inspection readiness Collaborate with External Quality Operations when required Escalate critical and major quality issues and advise leadership accordingly Build strong, effective collaboration across Global Quality Operations and cross-functional teams Qualifications About you You are an experienced quality professional with strong GMP and GDP expertise and a solid understanding of pharmaceutical operations. You are confident working in global, cross-functional environments and comfortable taking ownership of internal quality oversight and product release activities. With a structured, solution-oriented mindset, you manage multiple priorities effectively, communicate clearly with stakeholders, and drive continuous improvement. You are collaborative by nature and motivated by contributing to high quality standards that ensure safe, compliant medicines for patients worldwide. Key Qualifications Required University degree in Pharmaceutical Sciences, Biotechnology, Life Sciences or similar Curriculum fulfilling Sobi’s QP Delegate requirements (validated during the interview process) 3+ years’ experience in pharmaceutical or biotech operations (QA, production or relevant GMP/GDP roles) Desirable 2+ years’ experience in internal quality oversight or product quality (DS/API, DP or FG) Experience working in global organizations with English as the primary language Proven experience driving quality KPIs and improvement initiatives Experience interacting with Health Authorities such as FDA, EMA or others 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 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 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. Sobi Location: Sweden

Responsibilities

The Internal Quality Operations Manager is responsible for quality oversight of internal GMP and GDP activities, ensuring compliance with regulatory requirements. This role involves managing quality events, supporting inspections, and driving quality improvement initiatives.