GDP Quality & Supplier Oversight Lead

Sobi - Swedish Orphan Biovitrum AB (publ); Stockholms kommun; Hybrid; SEK 750.000 - 900.000; Vollzeit

Zusammenfassung

Sobi is seeking a QA GDP professional to provide quality oversight of supply-chain activities for finished products. As an RP Delegate, you will ensure GDP compliance across the global distribution network and collaborate with affiliates, distributors and partners.

This hybrid role is based at the Stockholm HQ, reporting to the Senior Director, Global Quality E2E Head. You will lead GDP quality matters, manage supplier quality, and contribute to inspections, risk-based decisions and continuous

Qualifikationen

• University degree in pharmacy, life sciences or another relevant field.
• At least five years of experience in the pharmaceutical or life-sciences industry with GDP knowledge.
• Experience handling deviations, change controls, temperature excursions, returns, quality agreements or comparable processes.
• Confidence working with external parties in an international environment.
• Excellent written and spoken English and strong communication skills.
• Occasional travel to partner sites, audits or inspections.

Aufgaben

• Act as an RP Delegate and support compliant distribution activities across Sobi’s network.
• Coordinate GDP quality matters with affiliates, distributors, pre-wholesalers and other marketing companies.
• Establish and maintain Quality Agreements.
• Provide GDP quality oversight of external suppliers and contribute to business reviews.
• Provide practical GDP advice and apply risk-based judgement to quality and supply-chain decisions.
• Lead or participate in internal inspections, external audits and authority inspections related to GDP.
• Manage operational quality activities including temperature excursions, returns, deviations, change controls and access program approvals.
• Support geographic expansion by onboarding new pre-wholesalers/wholesalers and developing SOPs.

Kenntnisse

GDP knowledge

Quality oversight

Cross-functional collaboration

English communication

Travel readiness

Ausbildung

Pharmacy or Life sciences degree

Jobbeschreibung

Sobi is seeking a QA GDP professional to provide quality oversight of supply-chain activities for finished products. As an RP Delegate, you will ensure GDP compliance across the global distribution network and collaborate with affiliates, distributors and partners.

This hybrid role is based at the Stockholm HQ, reporting to the Senior Director, Global Quality E2E Head. You will lead GDP quality matters, manage supplier quality, and contribute to inspections, risk-based decisions and continuous