United States onlyBeiGene 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 job holder is responsible for ensuring the commercial products at CMOs are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The job holder leads and develops a staff of Quality professionals to ensure the product quality from CMOs as well as closely work with Distribution and Regional Quality team to oversee commercial product on the end to end supply chain. The job location could be in US, EU or China i.e. should be close to where CMOs are based.
The scope of the role will include but not limited to the following,
- Both small molecule and large molecule commercial products
- For DS, DP, FP stages at CMO
- Including partnering products where BeiGene is the MAH for the market
- Managing quality issues and changes at CMOs
Essential Functions of the job:
- Lead Small Molecule and Large Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards.
- Perform batch record review
- Lead batch related deviation handling in investigation and effective CAPA implementation at CMO
- Manage change controls
- Perform batch dispositions
- Perform PIP (Person in Plant)
- Prepare batch related documents e.g. COA
- Manage temperature excursion from storage and transportation.
- Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes
- Advise and support Quality Agreement content, implementation, and updates.
- Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.
- Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required
- Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.
- Provide quality support on product commercial supply e.g. timely batch release
- Support GCP inspections in IMP manufacturing perspective
- Execute product recalls from commercial supply chain when needed
- Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines
Supervisory Responsibilities:
- Responsible for management, development and co-ordination of a medium sized team of direct staff who are based globally
- With strong cross culture leadership
- Accountable for financial control and for the management of related budgets such as headcount related and travel.
- Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
- Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.
Core Competencies, Knowledge, and Skill Requirements
- Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or Engineering
- Minimum 12 years pharmaceutical or biotechnology industry experience
- In-depth GMP experience in a quality and manufacturing function
- Prior experience in commercial GMP batch release
- In-depth knowledge of Quality principles, concepts, industry practices and standards
- Working Knowledge and experience with US, EU, ICH and/or China GMP regulations as well as international regulations
- Excellent interpersonal skills, including communication, negotiations, facilitations
- Experience in working in a cross-functional and international environment
- Good presentation skills
- Ability to work independently
- Spoken/Written fluency in English required
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Other Qualifications: N/A
Travel:
- May travel regionally and intercontinentally estimated up to 30%
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 fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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.
Taiwan only
