External Quality Operation Manager (hybrid - NC)

Sobi • Raleigh, NC

4d • Hybrid

About The Position

The 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. This is a hybrid role, requiring candidates to be located within commuting distance to the Morrisville, NC office and to be in the office 50% of the time.

Requirements

• 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

Nice To Haves

• 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
• Fluently spoken and written English

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 necessary
• 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 is 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 project 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

Benefits

• Competitive compensation
• 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
• Competitive 401(k) match
• Tuition and wellness reimbursements
• Comprehensive medical, dental, and vision package
• Additional recognition awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior