Sobi

Pharma

ExternalQualityOperationManager

$145–215k ~AI est. Raleigh, North Carolina, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“External Quality Operation Manager at Sobi. Skills: External quality oversight, CMO management, GMP compliance. Act as Single point of contact. Ensure compliance with Sobi Quality system”

Industry & Context.

Pharma

What They're Looking For.

Must Have

University degree or similar, 5+ years pharmaceutical experience, 1+ years external quality oversight

Nice to Have

2+ years global operation experience, English as main language

What You'll Do.

Act as Single point of contact

Ensure compliance with Sobi Quality system

Support release products by QP Delegate

Support External Service Provider qualification

Ensure Quality Technical Agreement established

Implement and maintain Quality Risk Assessment

Monitor remediation plans

Drive improvement opportunities

Assess product performance

Manage quality issues

Approve quality issues

Ensure Change requests managed

Support Quality Audits of CMO

Define strategy of implementation

Monitor key Quality transformation initiatives

Align with process stakeholders

Act as Quality representative

Assess CMO for HA inspection readiness

Support HA inspections/audits

Inform line manager of issues

How You'll Work.

Team & Collaboration

Cross-functional relationships; Global Quality Operations

Full Job Description

_At 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 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/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

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