Job Information
BeiGene Senior Director, CMO and Distribution Logistics, Clinical Supply Chain in San Mateo, California
General Description:
The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain vision and strategy providing leadership over the DP Supply Planning, CMO operation and Distribution management. Ensures organization effectively manages vendor relationships and activities and acts as point of escalation for CMOs performance issues for both operational execution and distribution. The position provides leadership, manages direct reports as well as mentors team members as required to ensure optimal performance. Represents DP Planning, CMO management and Distribution & Logistics on the Global Clinical Supply Chain Leadership Team and ensures strategic alignment to Global Clinical Supply Chain and BeiGene’s strategic goals. Builds strong relationships with BeiGene functional leadership (including but not limited to clinical Operation, Quality, Regulatory, CMC, and GRDS) to ensure alignment of organizations and prompt resolution of critical issues.
Has an expert working knowledge of supply chain best practices and experience working within a cGMP and GCP environment. Has strong cross-cultural awareness and communication skills to lead in a fast paced, multi- cultural company.
Essential Functions of the job:
Interface with internal manufacturing sites and external CMO/vendors on related activities for DP/FG and distribution operations, providing robust solutions and implementation actions.
Oversee the management of production schedules to maximize supply efficiency, minimize waste while identifying risk and developing mitigation plans by working with supply chain leaders and CMC project managers.
Act as point of escalation if deliverables and timelines are jeopardized, communicating to appropriate internal and external stakeholders as needed.
Participate in CMO Site visits as requested.
Ensure team supports QA and Legal in establishing QA and MSA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
Participate in Compliance group’s audit process from planning through implementation, result evaluation, and CMO response review.
Support inspection readiness activities as required. Drive the close out of audit commitments and CAPA’S as appropriate.
Oversee distribution and logistics teams for storage, Import & Export, distribution, drug return, destruction, and Depot Management.
Accountable for ensuring successful delivery of DP and FG delivery to depots and clinical sites.
Develop and maintain relationship with global Courier/broker vendors.
Oversee the development of the Import permit application strategy globally.
Ensure site/CMO/vendor metrics, key issues, production status, operational performance summary updates are tracked and reported by implementing KPIs.
Participate and lead process/performance improvement initiatives with cross functionally with stakeholders contributing to global/regional initiatives or programs.
Lead monthly Supply Review Meeting of CD&OP and present/report supply planning performance and related discussions.
Build strategic relationships with internal functional groups and ensure alignment.
Oversee the annual forecast and budgeting target vs. actual for CMO management /DP planning and distribution activities.
Responsible ensuring team supports investigation of exceptions to determine root causes, implement CAPAs and drive closure.
Ensure robust systems and processes are in place to enable execution of operational and logistical tasks in a cGMP compliant manner.
Collaborate and author department policies and procedures.
Supervisory Responsibilities:
- Lead Supply packaging team , CMO and distribution management team.in global locations including US, EU, and China for BeiGene. Manage direct reports as well as provide mentoring to their teams as required.
Competencies:
Experience working in a global, complex supply chain organization within the biopharma industry.
Experience leading multi-disciplinary department(s) and building up the team
Strong ability to collaborate and build strategic relationships with internal (Clinical Operations, Quality, CMC, Regulatory, etc.) stakeholders.
Demonstrates advanced knowledge of global clinical trials and the drug development process.
Experience in vendor oversight and managing external partnerships and relations.
Experience with biologics and small molecule supply chain.
Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11, and Annex 13).
Experience in deviation investigation and CAPA implementation.
Ability to work effectively in cross-functional and multi-cultural teams.
Education Required:
Bachelor or Master Degree in Science or Business Administration, Operations Management, or similar education required, Supply Chain Management, and/or Management of Science or equivalent filed is preferred.
Packaging experience is beneficial (small molecule, biologic devices).
Experience with Device Manufacturing, DeviceAssembly, and process validation is a plus
12+ years’ progressive experience
5+ years of people leadership and development experience
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills:
Proficient in Microsoft Office applications, Planning applications and models, IRT/IXRS systems, MRP/ERP systems
Other Qualifications:
Due to global nature of company early morning or evening meetings may be required
Travel: 30%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.