Quality Manager Contracts & Collaborations

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The incumbent will be responsible for supporting routine activities relating to BeiGene’s external GMP, GDP/GSP operations in Europe as well as internal BeiGene processes, ensuring procedures and systems are in place to support BeiGene’s product quality endeavors.

The position is in Basel, Switzerland, and has functional assignment to the Director, Head International Trading and Contracts & Collaborations Europe.

Essential Functions of the job:

1. Coordinate, drive, lead and troubleshoot the execution of Quality Agreements related to EU Distribution & Regional Quality with internal and external stakeholders to ensure that all Quality topics aspects are covered including full alignment with related master service agreements, inter-company agreements and amendments.
2. Ensure compliance of all Quality Agreements against GMP, GDP/GSP, Swiss law and internal guidelines and directives.
3. Take ownership of issues and collaborate with all required interfaces to drive issues to full resolution for internal and external stakeholders.
4. Keep an overview of internal and external Quality Agreements within the area of responsibility of EU Distribution & Regional Quality.
5. Monitor the performance metrics related to the Quality Agreements under the responsibility of EU Distribution & Regional Quality.
6. Support the trading in foreign countries activities.
7. Enable meetings with different internal and external stakeholders within various time zones.
8. Establish strong collaboration, exchange, and alignment with External and Internal Supply Quality and regional Quality organizations.
9. Work cross-functionally to support the development and update of policies and procedures in support of BeiGene's business needs.
10. Close collaboration with Swiss Responsible Person / Deputy Swiss Responsible Person to ensure compliance with legislative requirements as demanded by Swiss law.
11. Provide regular updates to management on assigned project progress and escalate challenges as needed.
12. Support the development of training materials and/or programs regarding all aspects of working area.
13. Other duties as assigned.

Qualifications and Experience:

1. Bachelor’s degree in science and 3+ years of experience in the pharmaceutical industry or combination of education and equivalent work experience.
2. Min. +3 years pharmaceutical or biotechnology industry experience.
3. GMP/GDP experience in a quality and/or audit function.
4. Extensive Knowledge of global and local law.
5. Extensive Knowledge of global and local contract design and local specifications.

Core Knowledge and Skill Requirements:

1. In-depth knowledge of GMP/GDPs, contract design and negotiation skills.
2. In-depth understanding of Quality principles, concepts, best industry practices, and international and industry standards as well as legal and financial interrelationships.
3. Strong project management experience and processes in managing resources towards meeting goals, completing projects, and resolving challenges.
4. Strong Presentation and Leadership Skills.
5. Strong experience presenting to upper management and large audiences.
6. Experienced in managing resources in setting and achieving development goals.
7. Experienced in managing projects towards process improvements.
8. Experienced working cross-region and departments with various stakeholders and cultures.
9. Spoken/Written fluency in English required.
10. Spoken/Written fluency in German/French/Italian preferred.
11. Spoken/Written fluency in Mandarin is a plus.
12. MBA is a plus.

Computer Skills:

1. PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio).
2. Veeva Vault Quality Docs; Veeva Vault Quality Suite; SAP; etc.
3. UL ComplianceWire; UL LearnShare.

Travel:

1. May travel approximately 10 – 20 %.

Global Competencies:

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

1. Fosters Teamwork.
2. Provides and Solicits Honest and Actionable Feedback.
3. Self-Awareness.
4. Acts Inclusively.
5. Demonstrates Initiative.
6. Entrepreneurial Mindset.
7. Continuous Learning.
8. Embraces Change.
9. Results-Oriented.
10. Analytical Thinking/Data Analysis.
11. Financial Excellence.
12. Communicates with Clarity.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.