- 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
- Hold a high-level education in pharmaceutical, biotech, or life sciences
- Possess at least 10 years of experience in pharmaceutical and biotech products
- Strong leadership skills with a proven track record with health authorities
- Deep understanding of GMP & GDP requirements and strategic planning
- Fluent in English with excellent communication and interpersonal skills
- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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Product Quality Lead - Stockholm, Sverige - Sobi
Beskrivning
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
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:
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
Additional Information
Why Join Us?
Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: