GDP Quality & Supplier Compliance Lead

Sobi; Stockholms kommun; Hybrid; SEK 750,000 - 1,100,000; Full time

Job summary

Sobi, a global biopharma company, seeks a quality professional to oversee GDP in our finished products distribution. As RP Delegate, you will ensure GDP compliance across our international network and collaborate with affiliates, distributors and external partners from Stockholm to Basel.

You will lead quality requirements, audits, and improvement initiatives, while maintaining strong communication with global stakeholders and maintaining high standards of patient safety and supply-chain

Qualifications

• University degree in pharmacy, life sciences or another relevant field.
• At least five years of experience in the pharmaceutical or life-sciences industry, with strong knowledge of GDP and quality activities across the supply chain.
• Experience handling deviations, change controls, temperature excursions, returns, quality agreements or comparable operational quality processes.
• Confidence working with external parties and cross-functional stakeholders in an international environment.
• Excellent written and spoken English, together with clear and effective communication skills.
• Ability to travel occasionally to meet partners or support audits and inspections.
• Experience supporting geographic expansion, establishing distribution models or onboarding new suppliers.
• Knowledge of GMP alongside your GDP expertise.
• Experience of acting as an RP Delegate, leading GDP audits or delivering internal GDP training.

Responsibilities

• 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, maintain Quality Agreements
• Responsible for the quality oversight of external suppliers and contribute to business review meetings.
• 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 relating to GDP activities.
• Manage operational quality activities, including temperature excursions, returns, deviations, change controls and approval processes for access programs.
• Support geographic expansion by assessing and onboarding new pre-wholesalers and wholesalers, and training and the development of SOPs.

Skills

GDP expertise

Quality oversight

Stakeholder management

English communication

Education

University degree in pharmacy or life sciences

Job description

Sobi, a global biopharma company, seeks a quality professional to oversee GDP in our finished products distribution. As RP Delegate, you will ensure GDP compliance across our international network and collaborate with affiliates, distributors and external partners from Stockholm to Basel.

You will lead quality requirements, audits, and improvement initiatives, while maintaining strong communication with global stakeholders and maintaining high standards of patient safety and supply-chain