Director, Distribution Quality

BeiGene; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

A leading biotechnology company is seeking a Quality Management Systems Lead to oversee GDP/GSP compliance for global distribution. You will engage with cross-functional teams, drive quality standards, and lead continuous improvement initiatives. Ideal candidates have extensive experience in the pharmaceutical industry and strong analytical skills. This position offers a dynamic environment focused on excellence and teamwork.

Qualifications

• Minimum of 10 years of experience in pharmaceutical or biotechnology industries.
• Proven expertise in GMP and GDP compliance.
• Extensive cold chain experience required.

Responsibilities

• Lead and improve Quality Management Systems for distribution of pharmaceutical products.
• Engage with teams to ensure compliance with GDP/GSP requirements.
• Support audits and inspections for GDP/GSP compliance.

Skills

Good Distribution Practice (GDP/GSP)

Project Management

Analytical Thinking/Data Analysis

Communication Skills

Education

Bachelor’s degree in science

Master’s degree in science or equivalent

Tools

Veeva Vault

SAP

MS Office (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)

Job description

Overview

BeOne 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:

This position reports to the Senior Director, Distribution Quality. Responsibilities include providing GDP/GSP expertise for distribution of investigational medicinal products and commercial products globally for BeOne, in accordance with regulatory expectations and applicable quality standards.

This position also deputizes for the Senior Director, as necessary.

Essential Functions of the Job

• Lead, develop and improve the Quality Management Systems for the distribution of pharmaceutical products, ensuring adherence to GDP/GSP requirements and other regulatory requirements and industry best practices.

• Engage with commercial and clinical teams to ensure quality is built into long term planning and that the proposed supply chain distribution models are compliant with current and future GDP/GSP requirements and expectations.

• Improve GDP/GSP knowledge and understanding throughout BeOne. Support fostering a culture of continuous improvement and excellence in quality management, provide training and support development of staff on GDP requirements. Provide GDP/GSP advice to Regional Quality teams.

• Drive quality consistency and standardization across Supply Chain and Distribution teams and other cross-functional teams, supporting operational excellence and quality management oversight to optimize processes and enhance the overall supply chain efficiency and reliability.

• Support audits and inspections to ensure GDP/GSP compliance. Prepare for and manage inspections by regulatory authorities, ensuring all necessary documentation and processes are in place and demonstrating a state of control.

• Establish and monitor key performance metrics of distribution processes to ensure that distribution activities comply with GDP/GSP requirements, maintaining the quality, safety and efficacy of pharmaceutical products throughout the supply chain.

• Cultivate productive and collaborative relationships across functional areas and geographies, including (but not limited to) Commercial, Pharmacovigilance, Medical, Supply Chain, Operations, Internal and External Supply Quality, Regulatory Affairs and Regional Quality teams.

• Leads and manages projects in remote settings, working autonomously and supporting various time zones.

Supervisory Responsibilities

• None

Requirements

• Bachelor’s degree in science

• Master’s degree in science or combination of education and equivalent work experience preferred

• Minimum of 10 years of experience in pharmaceutical or biotechnology industries with Good Distribution Practice (GDP/GSP) in a quality function, with proven expertise in GMP and GDP compliance.

• Extensive cold chain experience

• Worked in commercial environment, technical development and clinical environment experience is an asset

• Regional experience in a variety of geographical regions is an asset

Computer Skills

• PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)

• Veeva Vault, SAP

• UL ComplianceWire, UL LearnShare

• Ability to work on a computer (remotely) for extended periods of time

Travel: As required

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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

We are proud to be an equal opportunity employer. BeOne 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.