Product Quality Lead

Sobi

Sweden

Job Description

The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.

Key Responsibilities

Ensure end-to-end compliance for product manufacturing and life cycle management
Implement and maintain Quality Risk Assessment and KPIs
Lead complex change cases and coordinate product QA activities across markets
Provide guidance on product quality aspects and support site transfers
Participate in audits and inspections, and lead Product Governance boards
Design SOPs, contribute to operational development, and lead Quality aspect of Due Diligence processes

Qualifications

About you:

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

To be successful in this role you are a leader with the ability to manage challenging decisions in a logical and compliance manner, are comfortable in a global and complex environment with a Holistic business understanding. You have the skills to influence external Suppliers but also internally in a cross-functional environment to foster decisions and to propose solutions.