Sr QA Supplier Manager

at  Sobi

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, 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.

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:

• 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

Job Description
The QA 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 QA 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

WHY JOIN US?

We are a global company with over 1,800 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.

In order to be successful in this position you should have a great understanding of the GMP requirements. You are comfortable in a global and complex environment; able to coordinate people to reach our goals; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with the External Suppliers

• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• More than 7 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
• Proven track record with FDA; EMEA or other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals / tools
• Fluently spoken and written Englis

• Serve as the primary contact for all quality-related activities with external suppliers.
• Ensure compliance with GMP regulations and Sobi’s Quality System.
• Oversee supplier qualifications, and quality technical agreements.
• Release commercial products on QP Delegate
• Implement and maintain quality risk assessments and KPIs.
• Manage quality issues, audits, and change requests.
• Lead quality initiatives and act as a quality representative in projects.
  Qualifications
  All Sobi employees need to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.

In order to be successful in this position you should have a great understanding of the GMP requirements. You are comfortable in a global and complex environment; able to coordinate people to reach our goals; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with the External Suppliers

• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• More than 7 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
• Proven track record with FDA; EMEA or other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals / tools
• Fluently spoken and written English

Additional Information