External Quality Operation Manager (GMP) at Sobi

Raleigh, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

153000.0

Posted On

11 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, GDP Compliance, CMO Management, Quality Technical Agreements, Quality Risk Assessment, CAPA Management, Deviation Management, Batch Release, Audit Management, Tech Transfer, KPI Monitoring, Regulatory Affairs, Stakeholder Management, Health Authority Inspection Readiness, Pharmaceutical Quality Assurance, Project Management

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, 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 Job Description 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 an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners. Acting as the primary point of contact for these suppliers, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. You’ll be the bridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi’s commitment to delivering high‑quality medicines to patients worldwide. 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 Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement. Support release products to Markets 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 are 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 projects 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 Ensure the batch release as required 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 What You’ll Bring To thrive in this role, you’ll combine deep knowledge of GMP and GDP regulations with proven experience in quality oversight of Contract Manufacturing Organizations (CMOs). You’re confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions. You naturally build strong 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 in planning and prioritization, you coordinate multiple deliverables with precision. As a leader, you take pride in coaching and developing others, fostering a culture of accountability and high performance across the quality network. Additional Information 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 [email protected] Know Your Rights Sobi Location: United States

Responsibilities

Oversee the quality performance of external manufacturing partners to ensure all products meet GMP/GDP requirements and global quality standards. Act as the primary point of contact for CMOs, managing quality agreements, deviations, and regulatory compliance.