- 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
Job DescriptionThe 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:
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
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:
We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can't change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
Användare av yrket Product Quality Lead i Stockholm
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Jack Hooltin
Full Stack Developer
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seshachalam k
.Net Full stack developer | Azure | React
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Snehasis Biswas
Process Manager, Project Manager, Customer Value
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Danjel Strandberg
Customer Success