Director, CMO Vendor Management

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 job holder is responsible for establishing, maintaining, and continuously improving the end to end CMO/Vendor management process. The role has global responsibility and accountability for the Compliance and Quality Assurance management of these CMOs/Vendors. The job holder leads and develops a staff of Quality professionals located globally and close to these CMOs/Vendors. The job location could be in US, EU or China.
The scope of the role will include but not limited to the following,

• As global process owner of CMO/Vendor quality management
• Will include both clinical and commercial stage CMOs and Vendors in global clinical and commercial supply chain.
• Will include material suppliers, DS, DP and FP CMOs and Vendors
• Will ensure that CMOs and Vendors are qualified and their performance is monitored.
• Will provide leadership for CMO/Vendor performance management in a close and cooperative relationship with internal key stakeholders.
• A team leader with members located in a number of locations therefore culture awareness is essential.
• Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams.
  

Essential Functions Of The Job

• Establish, maintain, and continuously improve CMO/Vendor management process
• Ensure quality performance at CMOs and Vendors are in line with regulatory requirements and BeiGene’s standards by providing sufficient oversight.
• Perform vendor due diligence, selection, and qualification by providing quality inputs and make decisions from quality perspective at product development stages from development to commercialization by applying phased appropriate GMP principles.
• Manage Quality Assurance Agreement process and ensure the QAA is in place and updated according to the regulatory requirement, BeiGene’s standards, and in line with commercial agreements, intercompany agreements.
• Perform regular quality performance review with CMOs and Vendors, typically by representing Quality at Business Review meetings (e.g. as quality representative in JSC committee), and escalate any quality or compliance issue to senior management when needed.
• Set up process for getting quality performance information from product quality team
• Accountable for successful Regulatory Inspections, including Pre-approval inspections at CMOs and Vendors by monitoring progress and providing support
• Lead, coordinate and support any quality improvement activities cross-functionally when needed at CMOs and Vendors
• Support BeiGene audit at CMOs and Vendors
• Significant input to the development of strategies and lead the implementation of these to improve the overall performance of the global external supplier portfolio over time.
• Closely collaborate with BeiGene's Manufacturing, Supply Chain, Regulatory CMC and other Quality teams.
• Monitor regulatory environment and ensure vendor management related regulation changes will be timely captured and reflected in BeiGene internal standards
  

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 resource planning according to business demand as well as 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.
• Inspire and encourage team members and create a great place to work for their personal development and career success.
  

Core Knowledge And Skill Requirements

• Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or Engineering
• Min 10 years pharmaceutical or biotechnology industry experience
• In-depth GMP experience in a quality and manufacturing function
• Worked in the field of vendor qualification, vendor oversight, auditing and or/negotiation of Quality Agreements before
• Experience in both an IMP and a commercial environment would be an asset
• 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)
  

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
  

Salary Range: $157,400.00 - $217,400.00 annually
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.