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.
General Description:
The role is responsible for overseeing end-to-end quality operational activities and programs related to commercial manufacturing at CMOs. Manages QA operational activities that support commercial products supply related cGMP activities including manufacturing, testing, packaging, release, and distribution of drug substance and drug product under applicable Regulations (US, EU, CN, etc.), ICH standards, and BeiGene processes and procedures.
Essential Functions of the job:
- Author/Review standard operating procedures related to function and department and identify opportunities to streamline systems and processes.
- Provide Quality support for cGMP external manufacturing operations at CMOs. Drive, lead and troubleshoot quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
- Provide Quality guidance of cGMP external manufacturing operations (CMO). Advise on Quality Agreement content and support Quality Agreement implementation and updates.
- Ensure CMOs are compliant for regulatory inspections and monitor progress of inspections. Perform on site quality visit (PIP) at request. Participate in quality audits that directly impact assigned projects.
- Review and approve CMO documents, like EBR/ CC, deviation and validations related.
- Provide quality support for batch disposition of drug substance, drug product and finished product.
- Work with departmental key stakeholders and internal staff to ensure processes and procedures remain in a compliant state globally.
- Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements.
- Work with regulatory to author and review quality sections of regulatory submissions.
- Other duties as assigned.
Experience
- Minimum 5 years of experience in Quality function of pharmaceuticals or biotechnology industry.
Computer Skills:
- Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
- Understanding of Quality best practices, including familiarity with Quality Systems Regulations and GxPs,
- Strong knowledge of Good Manufacturing Practices (e.g. EU, US, CN, PICS) and ICH guideline
- Experienced with CMO management.
- Experienced in supporting projects towards process improvements.
- Experienced in small/large molecule product quality.
- Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment.
- Experienced working cross-department with CMC, regulatory and SC. Ability to work independently with scientific/technical personnel.
- Effective oral and written communication skills.
- Oral and written proficiency in English required.
Travel:
Occasionally, as required.
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
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
