Senior QA Supplier Manager

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
• Summer Fridays
• 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

The Senior Quality Supplier Manager 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 Senior Quality Supplier 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 and will serve as deputy for Head of Quality NA.

We are excited to invite applications for the Senior Quality Supplier Manager position, a full-time remote opportunity. To be considered, candidates must reside in North Carolina. In this role, you will have the flexibility of remote work with the added opportunity for occasional travel as needed.

Key Responsibilities

• Act as single point of contact for all quality-related activities with the external supplier.
• Ensure that all aspects of handling, manufacturing, and distribution of products are in compliance with Sobi Quality System, the effective Quality Technical Agreement, and that they meet relevant cGMP regulatory requirements.
• Lead external supplier qualification.
• Establish Quality Technical Agreement and ensure valid QTA clearly defines roles & responsibilities between Sobi and the external supplier.
• Implement and maintain Quality Risk Assessment and KPIs on quality external activities.
• Define & monitor remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product quality performance.
• Request, review GMP, GDP documentation as defined in the QTA and Sobi procedures.
• Ensure external supplier 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 requirements.
• Manage/approve quality issues (deviations, CAPA, and complaints) as per QTA and Sobi requirements.
• Responsible for ensuring change requests either from the external supplier or from Sobi are managed according to the QTA and Sobi requirements.
• Responsible for ensuring Quality Audits of the CMO are performed according to Sobi requirements and the QTA.
• Define strategy of 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 external supplier, e.g., Tech Transfer, Launch.
• Assess and ensure external supplier readiness for Health Authorities inspections.
• Support inspections/audits of Sobi.
• Responsible for informing Sobi management and cross-functional teams of all critical & major issues and escalating any issues as per Sobi escalation policy.
• Ensure good collaboration is maintained within the product team.

Qualifications

• Bachelor’s degree or equivalent education/degree in life sciences or healthcare with relevant area such as pharmaceutical, biotech, or life science industry.
• More than ten (10) years of experience within pharmaceutical, biotech product.
• Extensive experience in QA operation, production, or other relevant area (GMP, GDP).
• Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC, LATAM, etc.
• Strong understanding of risk a