External Quality Operation Manager (GMP)

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, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Join Sobi's mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety.

As anExternal Quality Operations Manager (EQOM), you'll play a pivotal role in overseeing thequality performance of external manufacturing partners. Acting as theprimary point of contactfor these suppliers, you'll ensure that every batch produced meetsGMP/GDP requirements, aligns withQuality Technical Agreements, and upholdsSobi's global quality standards.

You'll be thebridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi's fastgrowing global footprint.

This role offers the opportunity to work crossfunctionally withManufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi's commitment to delivering highquality medicines to patients worldwide.

Key responsibilities:

• Perform asEQOM to act as Single point of contactfor all quality relatedactivities at theContract Manufacturing Organization (CMO)

• Ensure that all aspectsof handling, manufacturing,distribution of productsare in compliance withSobiQuality system, the effectiveQualityTechnicalAgreement(QTA), that they meetrelevantCGMP regulatory requirement.

• Support release products to Markets

• Support theExternalService Provider (CMO)Qualification

• EnsureQuality TechnicalAgreement(QTA) beestablishedappropriatelyand ensurevalid QTAclearly defines roles & responsibilitiesbetween Sobi and the External Supplier

• Ensure implementation andmaintainingQuality Risk Assessment and KPIson Quality External activities.Guide defining&monitoringremediation plansto ensure that issues are suitably addressed.Drive or supportimprovement opportunitiesfor processes and product Quality performance

• EnsureCMOprovides product reviewsor data(APQR/PQRs, stability reports)as specified in the QTA. Assessthe performance of the product and the processas perSobi requirement

• Manage/approvequality issues (deviations,CAPA andcomplaints) as per QTA and Sobi requirement

• EnsurethatChange requests either fromCMOor from Sobi are managed according to the QTA and Sobi requirements

• SupportthatQuality Audits of the CMOareperformed according to Sobi requirement and the QTA

• Lead todefinestrategyof implementationand monitoringof key Quality transformation initiativesand align with all process stakeholders outside of Quality organization

• Lead or act as Quality representative in projectsrelated toCMOegTech Transfer, Launch

• Assess and ensureCMOforHealthAuthorities(HAs)inspectionreadiness

• SupportHAinspections/audits of Sobi

• Responsible to informthe line managerand cross functional teamsof all critical &major issuesand escalateany issues as per Sobi escalation policy

• Ensure a good collaboration ismaintainedwithin theGlobal Quality Operations and cross-functionally

• Ensure the batch release asrequired

Required:

• High level education (university degree or similar) within relevant area such aspharmaceutical,biotechor life science

• More than5yearsof experiencewithinpharmaceutical,biotechproduct. Experience in QA operation,productionor other relevant area(GMP, GDP)

• More than1years of managing external quality oversight of CMOs

• Curriculum isrequested for evaluating the batch release qualification requirement

• Fluently spoken and writtenEnglish
  
  Desired:

• More than 2 years of working in global operation environment with English as a main language

• Proven experience ofleading Quality KPI assessment and improvement at CMOs

• Proventrack recordwithFDA; EMEA or other Health Authorities

• Strong understanding ofrisk assessment and risk management fundamentals / tools

What You'll Bring

To thrive in this role, you'll combinedeep knowledge of GMP and GDP regulationswith proven experience inquality oversight of Contract Manufacturing Organizations (CMOs).

You're confident operating in aglobal, fastmoving environment, using yourleadership and interpersonal skillsto influence external partners and drive collaborative decisions.

You naturally buildstrong relationships- both within Sobi and with CMOs - and you know how to balance compliance with practical solutions that keep supply moving.

Highly organized and skilled inplanning and prioritization, you coordinate multiple deliverables with precision.

As a leader, you take pride incoaching and developing others, fostering a culture of accountability and high performance across the quality network.

Compensation and Total Rewards at Sobi

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $130,000-$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

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.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com

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