Quality Assurance Specialist, Commercial

BeOne Medicines; Basel; Vor Ort; CHF 87.000 - 108.000; Vollzeit

Zusammenfassung

BeOne Medicines Basel seeks a Quality Assurance Specialist, Commercial, to execute Work Center Team activities for externally manufactured APIs, drug products and finished goods.

The role involves batch record review, batch disposition, and maintaining eQMS records to enable compliant, timely product release across the global commercial supply network. Applicants should hold a bachelor’s degree and 2+ years in pharma, with GMP knowledge and collaboration across functions.

Qualifikationen

• Bachelor’s degree in scientific discipline or equivalent with 2+ years experience.
• Experience in pharmaceutical or biotech industries with GMP exposure.
• Commercial QA experience is preferred.
• Experience navigating external manufacturing models is a plus.

Aufgaben

• Support multiple commercial products and CMOs while managing competing priorities.
• Perform batch record review and data verification for APIs, drug products and finished goods.
• Prioritize and execute batch review activities to support supply commitments.
• Perform batch disposition activities and document quality for product release.
• Escalate quality or compliance observations identified during batch review.
• Initiate and manage quality system records (deviations, CAPAs) in eQMS.
• Perform data verification and document checks for inspections and regulatory requests.
• Support regulatory request management including document retrieval and archival.
• Maintain trackers and metrics for batch review deliverables.
• Author, revise and maintain internal quality documents (SOPs, work instructions).
• Collaborate with CMO managers and cross-functional stakeholders for batch disposition and continuity.
• Perform other WCT responsibilities as assigned.

Kenntnisse

GMP principles

Quality systems

Analytical thinking

Cross-functional collaboration

Document verification

Ausbildung

Bachelor’s degree in scientific discipline

Tools

eQMS

Microsoft Office

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

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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous 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.