External Quality Operation Manager; hybrid - NC

External Quality Operation Manager (hybrid - NC)

• Full-time
• Sobi
  
  Location:
  
  United States

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 mission and culture at Sobi North America get us excited to come to work every day. Here’s why you should consider joining 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

The External Operation Manager (EQOM) is responsible for a wide range of activities and tasks related to the quality oversight of external suppliers in charge of the manufacturing activities for a product. Act as the single point of contact with the external supplier, ensuring compliance with GMP & GDP regulations, the Quality Technical Agreement, and Sobi procedures and policies.

Key responsibilities:

• Act as the single point of contact for all quality-related activities at the Contract Manufacturing Organization (CMO)
• Ensure compliance of all aspects of handling, manufacturing, and distribution of products with Sobi Quality system and CGMP regulatory requirements
• Support product release by QP delegate according to delegation documents, when necessary
• Support External Service Provider (CMO) qualification
• Establish and maintain a valid Quality Technical Agreement (QTA) that clearly defines roles and responsibilities between Sobi and the external supplier
• Implement and maintain Quality Risk Assessment and KPIs on external activities. Guide the definition and monitoring of remediation plans to ensure issues are addressed. Drive or support improvement opportunities for processes and product quality performance
• Ensure the CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA, and assess product and process performance per Sobi requirement
• Manage and approve quality issues (deviations, CAPA, and complaints) as per QTA and Sobi requirements
• Ensure that change requests from CMO or Sobi are managed according to the QTA and Sobi requirements
• Support quality audits of the CMO performed according to Sobi requirement and the QTA
• Define strategy for implementation and monitoring of key quality transformation initiatives and align with all process stakeholders outside of the Quality organization
• Act as Quality representative in projects related to CMO (e.g., tech transfer, launch)
• Assess and ensure CMO inspection readiness for Health Authorities (HA)
• Support HA inspections/audits of Sobi
• Inform line manager and cross-functional teams of all critical and major issues and escalations per Sobi escalation policy
• Maintain good collaboration within Global Quality Operations and cross-functionally

Required qualifications:

• University degree or equivalent in pharmaceutical, biotech, or life science
• More than 5 years of experience in pharmaceutical/biotech product QA operation, production, or related area (GMP, GDP)
• More than 1 year of managing external quality oversight of CMOs
• Curriculum in batch release qualification requirement evaluation
• More than 2 years working in a global operations environment with English as a main language
• Proven experience 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

Compensation and Total Rewards at Sobi

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

Base salary range for this role: $115,000 - $140,000, plus short-term and long-term bonuses. Eligibility will be discussed during the interview process.

All Sobi employees must demonstrate behaviors in line with Sobi’s core values:
Care, Ambition, Urgency, Ownership, and Partnership.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and…