32 applicants

Company

Sobi - Swedish Orphan Biovitrum AB (publ) · 7 hours ago

Senior QA Supplier Manager

Waltham, MA

Full-time

Remote

Senior Level, Lead/Staff

$130K/yr - $150K/yr

10+ years exp

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Pharmaceutical experienceBiotech experienceQA operations experienceGMP knowledgeGDP knowledgeUS regulations knowledgeEuropean regulations knowledgeRisk assessmentRisk management toolsGCP requirements knowledgeFluent EnglishDiplomatic skillsCritical reasoning

Required

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 assessment and risk management fundamentals/tools.

Fluently spoken and written English.

Ability to travel approximately 25% of the time.