External Quality Operation Manager (hybrid - NC)

Company DescriptionAt Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you!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 workGenerous time off policyOpportunity to broaden your horizons by attending popular conferencesEmphasis on work/life balanceCollaborative and team-oriented environmentMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob DescriptionThe External Operation Manager (EQOM)is responsible for a wide range of activities/tasks related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the External Quality Operation Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.Please note that this is a hybrid role - candidates need to be located within commuting distance to our Morrisville, NC office and able to be in the office 50%.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, that they meet relevant CGMP regulatory requirement.Support the release products by QP Delegate according to delegation documents, when necessarySupport the External Service Provider (CMO) QualificationEnsure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External SupplierEnsure 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 performanceEnsure 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 requirementManage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirementEnsure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirementsSupport that Quality Audits of the CMO is performed according to Sobi requirement and the QTALead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organizationLead or act as Quality representative in project related to CMO eg Tech Transfer, LaunchAssess and ensure CMO for Health Authorities (HAs) inspection readinessSupport HA inspections/audits of SobiResponsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policyEnsure a good collaboration is maintained within the Global Quality Operations and cross-functionallyQualificationsRequired:High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life scienceMore 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 CMOsCurriculum is requested for evaluating the batch release qualification requirementDesired:More than 2 years of working in global operation environment with English as a main languageProven experience of leading Quality KPI assessment and improvement at CMOsProven track record with FDA; EMEA or other Health AuthoritiesStrong understanding of risk assessment and risk management fundamentals / toolsFluently spoken and written EnglishAdditional InformationCompensation and Total Rewards at SobiAt 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.Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as:A competitive 401(k) match to support your financial future.Tuition and wellness reimbursements to invest in your personal and professional growth.A comprehensive medical, dental, and vision package to prioritize your health and well-being.Additional recognition awards to celebrate your achievements.The base salary range for this role is $115,000-$140,000. 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