QA Supplier Manager

4 days ago

Stockholm, Stockholm, Sweden Sobi Middle East FZ LLC Full time

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application

At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description

The Quality Supplier Manager is responsible for a wide range of activities related to the quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the Quality Supplier Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement, and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.

Key Responsibilities:

  1. Serve as the primary contact for all quality-related activities with external suppliers.
  2. Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
  3. Oversee product release, supplier qualifications, and quality technical agreements.
  4. Implement and maintain quality risk assessments and KPIs.
  5. Manage quality issues, audits, and change requests.
  6. Lead quality initiatives and act as a quality representative in projects.
Qualifications

In order to be successful in this position, you should have a great understanding of the GMP & GDP requirements. You are comfortable in a global and complex environment; have interpersonal and leadership skills with the ability to influence external suppliers in a cross-functional environment to foster decisions and propose solutions. Furthermore, you have great collaborative skills to develop strong relationships within Sobi but also with the external suppliers.

Degree of at least 160 university credits (according to the old system, corresponds to 240 university credits in the current system) in the field of pharmacy, medicine, veterinary medicine, chemistry, technology or natural science, including courses in inorganic, organic, analytical, physical and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology and toxicology, microbiology and pharmacognosy (QP requirements).

More than 10 years of experience within pharmaceutical or biotech products. More than 5 years experience in QA operation or external quality including supplier quality management (GMP, GDP).

In-depth understanding of GMP requirements of FDA, EMEA, or other health authorities.

Strong understanding of risk assessment and risk management fundamentals/tools.

Excellent verbal and written communication skills.

Fluently spoken and written English.

Additional Information

How to apply

We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.

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:

• Emphasis on work/life balance

• Collaborative and team-oriented environment

• Opportunities for professional growth

• Diversity and Inclusion

• Competitive compensation for your work

• Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.

Sobi is a global company with over 1,800 employees in more than 30 countries and is committed to the societies where we operate. We are a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases, providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi's share is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

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 groundbreaking treatments, we help make medicine more accessible and open 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.

#J-18808-Ljbffr

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