Senior QA Specialist

About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

BeiGene 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.

Job Description:

General Description:

The incumbent is responsible for set up and maintenance of phase-appropriate quality management systems to support BeiGene CGT product development and ensuring adherence to global regulatory requirements.

Essential Functions of the job:

• Harmonize with BeiGene Global Quality Standard and changing regulations to achieve continual improvement to support BeiGene TW Cell Therapy.
• Continually set up and maintain the phase-appropriate quality management system for TaiWan Cell Therapy in compliance with BeiGene Global Quality Standard and US cGMP, PIC/S GMP and cGTP to support product development.
• Manage governance and procedure document in QMSs and responsible the workflow of controlled document implementation.
• In collaboration with External supply quality team for vendor management.
• Responsible for controlled document archiving, issuing and maintenance such as controlled document/batch record issuing, label issuing, GXP document/record archiving, etc.
• Responsible for raw material qualification and release process such as checking record review, COA review, testing result review, and label issuing.
• Handle quality events such as change control, deviation, CAPA, risk assessment, compliant and recall are executed in time and compliant with SOP and regulatory requirement.
• Manage and review on facility, equipment, instrument qualification and commission.
• Review batch record, test reports, EM record, ongoing stability data and so on to release/reject cell bank/final product.
• Review the protocol and report of analytic method verification/validation.
• Review the protocol and report of aseptic process/process validation
• Monitor and negotiate with contract facility to ensure GMP compliance of their service.
• Support quality internal audit to comply with BeiGene quality standard and ensure the GMP/GTP/GDP requirements are met during HA inspection.
• Support and coordinate with Global Compliance for third Party WH and distributor qualification (typically for Cold-Chain products), ensure compliance of GDP activities.
• Conduct GMP, GTP related training, to ensure operations of business functions are fully compliant with quality standard and regulations. 
• Review the quality event trend and KPIs, support the senior leadership to proceed quality oversight through Quality Management Review.
• Participate in department budget’s estimate and planning.

Qualification Required:

Core Competencies, Knowledge and Skill Requirements

• In-depth knowledge of GMPs, GTP, FDA, EMA, USP and EP guidance.
• Experience with regulatory compliance inspections 
• In-depth knowledge of quality principles, concepts, industry practices and standards on aseptic product
• Knowledge of quality management on CGT
• Excellent verbal, written and interpersonal communication skills.
• Ability to analyze and resolve issues calmly under tight timeline and uncertainty
• Ability to work independently with departmental and interdepartmental subteams.

Communication & Interpersonal Skills

•  Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail

Experience

• 3+ year pharmaceutical or biotechnology industry GMP experience
• 2+ years’ experience in quality management of CGT
• Demonstrated experience in driving cross-functional project
• Agility in change
• Experience on tight timeline and uncertainty project of developing product is a plus
• Fluent English in spoken and written

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

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