Quality Assurance Specialist, Commercial

BeiGene; Basel; Vor Ort; CHF 87.000 - 108.000; Vollzeit

Zusammenfassung

BeOne is seeking a Quality Assurance Specialist, Commercial, to support batch record review, disposition, and regulatory readiness for externally manufactured products. The role requires GMP knowledge and collaboration with CMOs to ensure compliant product release.

You will maintain eQMS records, generate quality documents, and track WCT deliverables while communicating with cross-functional teams. A bachelor’s in a scientific field and 2+ years of biotech experience are required.

Qualifikationen

• Bachelor’s degree in a scientific discipline or equivalent with 2+ years of experience.
• Experience in the pharmaceutical/biotech industry and GMP-regulated Quality functions.
• Commercial Quality Assurance experience preferred; external manufacturing experience is a plus.

Aufgaben

• Review batch records for commercial APIs, drug products and finished goods.
• Perform batch disposition and compile quality information for release.
• Manage quality system records (deviations, CAPAs) in eQMS and track lifecycle.
• Support regulatory requests with document retrieval and archival readiness.
• Maintain trackers for batch review status and WCT deliverables, and author SOPs.

Kenntnisse

GMP principles

Quality systems

ICH guidelines

Risk-based quality

Independent work

Analytical thinking

Problem solving

Communication skills

Detail oriented

Cross-functional collaboration

Ausbildung

Bachelor’s degree in scientific discipline

Tools

Microsoft Office

eQMS

Jobbeschreibung

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 Quality Assurance Specialist, Commercial, executes Work Center Team (WCT) activities for externally manufactured commercial APIs, drug products, and finished goods. This role is responsible for batch record review, batch disposition, quality system execution, and regulatory activities that enable compliant, risk-based, and timely commercial product release across the global commercial supply network.

Essential Functions of the job:

• Support multiple commercial products and CMOs while managing competing priorities in a fast-paced environment.
• Perform batch record review and data verification for commercial APIs, drug products and finished goods manufactured at CMOs, in accordance with approved procedures.
• Prioritize and execute batch review activities to support commercial supply commitments and product availability.
• Perform batch disposition activities, including compilation, verification, and documentation of quality information supporting commercial product release.
• Escalate quality or compliance observations identified during batch review in accordance with established procedures.
• Initiate and manage quality system records (e.g., deviations, CAPAs) within the electronic Quality Management System (eQMS), including lifecycle tracking through closure.
• Perform data verification and document completeness checks to support inspections, audits and regulatory requests.
• Support regulatory request management, including document retrieval, archival and readiness for repeat requests.
• Maintain trackers and metrics related to batch record review, record status and WCT deliverables.
• Author, revise and maintain internal quality documents (i.e., SOPs, work instructions) as assigned.
• Collaborate with CMO Managers and cross-functional stakeholders to support batch disposition, issue resolution and commercial supply continuity.
• Perform other WCT responsibilities as assigned.

Education

• Bachelor’s degree in scientific discipline or equivalent combination of education and 2+ years of work experience.

Required Experience

• Experience in the pharmaceutical or biotechnology industry
• Experience working in a GMP-regulated Quality function
• Commercial Quality Assurance experience preferred
• Previous experience navigating external manufacturing models would be an advantage

Knowledge, Skills, and Abilities

• Strong understanding of GMP principles and pharmaceutical quality systems.
• Working knowledge of pharmaceutical GMP requirements, including ICH Q7, ICH Q9, ICH Q10, 21 CFR Parts 210/211, EU GMP, and applicable global regulations.
• Ability to support risk-based quality activities and quality system execution in accordance with established procedures and governance.
• Ability to work independently in a regulated environment and manage competing priorities.
• Strong analytical, problem-solving and organizational skills.
• Excellent written, verbal and interpersonal communication skills.
• High attention to detail and ability to collaborate cross-functionally.

Computer Skills

• Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Teams)
• Experience with electronic Quality Management Systems (eQMS) required

Travel

• Approximately 5 - 10% travel may be required

Salary Range Switzerland: 86,600.00 CHF - 108,200.00 CHF

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial MindsetContinuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer. 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.