Senior Director, Distribution Quality

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 position will report to the Head of Distribution & Regional Quality. The Senior Director, Head of Distribution Quality, will provide GDP / GSP expertise and supervise distribution of IMPs and commercial products globally for BeiGene and ensure the compliant supply with medicinal products.

The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job :

• Develop and implement, manage complete scalable global quality strategies and QMS for the distribution of pharmaceutical products, ensuring adherence to GDP / GSP requirements and other regulatory requirements and industry best practices.
• Collaborate with cross functional teams to establish and maintain robust quality systems throughout the distribution process from manufacturing to final release to the market.
• Point of Quality contact for all global distribution topics for Commercial and Investigational Medicinal Products. Manage and lead the distribution quality related activities and processes (Cold chain management, Lane risk assessment, shipping validation, deviations, temperature excursion) within the distribution network providing timely resolution and escalation as needed.
• Drive quality consistency and standardization across Commercial and Supply Chain teams, supporting operational excellence, KPI creation and quality management oversight through monitoring of performance metrics to optimize distribution process, reduce deviations and enhance the overall supply chain efficiency.
• Engage with commercial business leaders to ensure quality is built into long term planning and is launch ready and is future fit for the proposed commercial models .
• Accountable to the brand protection team for the quality requirements within the working group framework and global standard.
• Conduct risk assessments and establish risk mitigation plans to enhance the reliability and efficiency of the global distribution network.
• Lead and mentor team to develop culture of continuous improvement and accountability.
• Establish KPI to incorporate into management / business review to monitor and evaluate the effectiveness of the global quality distribution program.
• Cultivate productive and collaborative relationships, across functional areas and geographies, including Commercial, Pharmacovigilance, Medical, Supply Chain, Operations and the Quality Management Systems team and Affiliate quality teams.
• Participate and conduct regular assessments and develop meaningful KPIs with distribution partners and suppliers to ensure that they are working to the BG quality standards.
• Monitor industry trends, regulations and best practices to continually enhance the distribution program.
• Set up a network forum with Supply Chain, Trade and Export to align and standardize global practices.

Experience :

• Bachelor’s degree in science or combination of education and equivalent work experience
• More than 12 years pharmaceutical or biotechnology industry experience.
• Extensive GDP and GSP experience in a quality function.
• Extensive cold chain experience
• Worked in commercial environment, technical development and clinical environment experience is an asset as well as regional experience in US, EU, APAC

Core Knowledge and Skill Requirements :

• Ability to build up a team and effectively manage staff.
• In-depth knowledge of GDPs and GSPs.
• In-depth knowledge of Quality principles, concepts, industry practices and standards.
• Working Knowledge and experience with regional pharmaceutical regulations and experience in working with regional Health Authorities like FDA, EMA, PMDA; TGA; MFDS and others.
• Excellent verbal, written and interpersonal communication skills.
• Ability to work independently with scientific / technical personnel.
• Experience with regulatory compliance inspections.
• Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
• Must possess strong presentation skills to speak effectively before groups; ability to respond.
• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
• Strong Project Management Skill Set.

Computer Skills :

• PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)
• Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP
• UL ComplianceWire; UL LearnShare

Travel :

• May travel approximately 25 %
• Ability to work on a computer for extended periods of time

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
Vor 22 Tagen