Quality Assurance Supplier Manager

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

Quality Assurance Supplier Manager

Role & Function

The 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 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. #LI-remote

Key Responsibilities

• Act as Single point of contact for all quality related activities at the External Supplier. Ensure that all aspects of handling, manufacturing, testing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement, that they meet relevant cGMP regulatory requirement. Establish Quality Technical Agreement and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier. Manage / approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement. Release products according to delegation documents.
• Lead External supplier Qualification. Responsible for ensuring Quality Audits of the CMO is performed according to Sobi requirement and the QTA
• Act as Quality representative in project related to External supplier eg Tech Transfer, Launch
• Assess and ensure External Supplier readiness for Health Authorities inspections. Support inspections/audits of Sobi
• 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 requirement
• Responsible to inform Sobi management and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy
• Responsible for ensuring Change requests either from the External Supplier or from Sobi are managed according to the QTA and Sobi requirements. Request, review GMP, GDP documentation as defined in the QTA and Sobi procedures
• Implementation 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
• Ensure a good collaboration is maintained within the product team

Qualifications

• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• More than 7 years of experience within pharmaceutical, biotech product. Experience in QA/QC operation, production, testing or other relevant area (GMP, GDP)
• Proven track record with FDA, EMA or other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals / tools
• Fluently spoken and written English

Personal Attributes

In order to be successful in this position you should have a great understanding of the GMP & GDP requirements. You are comfortable in a global and complex environment; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with the External Suppliers. In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

Location

The position will be based in United States.

Reporting to

Head QA North America

Recruitment contact & how to apply

If you are interested in applying for this position, please submit your CV and cover letter through the apply button above.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to prov