Associate Director, Distribution Quality
Vor 7 Tagen
General Description:
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The position will report to the Senior Director, Distribution Quality, will provide GDP/GSP expertise and manage day to day operations for distribution of IMPs and commercial products globally for BeiGene.
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 QMS for the distribution of pharmaceutical products, ensuring adherence to GDP/GSP requirements and other regulatory requirements and industry best practices.
- Manage distribution quality related activities, including cold chain, lane risk assessment, shipping validation, change control, deviations investigation, temperature excursion within the distribution network providing timely resolution and escalation as needed.
- Manage and oversight the distributors, LSPs and TSPs. Conduct Due Diligence as needed.
- Support HA inspections and internal audits.
- Establish and monitor of key performance metrics of distribution process.
- Work with commercial business team and other quality functions to support the product launch and market expansion.
- Cultivate productive and collaborative relationships, across functional areas and geographies, including Commercial, Supply Chain, External Supply Quality, Internal Supply Quality and Regional Quality teams, to maintain robust quality systems throughout the distribution process to the market.
Experience:
- Min 7 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 EU.
Core Knowledge and Skill Requirements:
- Indepth knowledge of GDPs.
- Indepth 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 and others.
- Good verbal, written and interpersonal communication skills.
- Ability to work independently with scientific/technical personnel.
- Experience with regulatory compliance inspections.
- Must possess strong presentation skills to speak effectively before groups; ability to respond.
- Good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
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 %
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 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.-
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