Director, Global Clinical Supply Compliance

BeiGene, Ltd.; United States; Remote; USD 168,000 - 229,000; Full time

Job summary

A leading global oncology company is seeking a Director of Global Clinical Supply Compliance to manage compliance-related needs in the pharmaceutical domain. This role involves driving compliance activities, supporting global initiatives, and ensuring transparency in operations. Candidates should possess a strong ethical background, leadership skills, and substantial experience in drug development.

Benefits

Health coverage

401(k)

Stock options

Qualifications

• 10+ years in pharmaceutical/biotech drug development.
• 3+ years in GCP-related quality assurance.
• Knowledge of GMP, GDP, and regulatory environment.

Responsibilities

• Drive compliance activities within Global Clinical Operations.
• Lead global initiatives to ensure GMP and GDP compliance.
• Support inspection preparations for health authority inspections.

Skills

Leadership

Collaboration

Judgment

Strong ethics

Education

Bachelor’s Degree

Tools

Word

Excel

PowerPoint

Visio

Outlook

Job description

Director, Global Clinical Supply Compliance

Apply locations: Remote (US) | Time type: Full time | Posted on: Posted 3 Days Ago | Job requisition id: R29526

BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer.

General Description:

The Director of Global Clinical Supply Compliance builds, collaborates, and manages key relationships to support and understand the compliance-related needs of the business. They drive compliance activities within Global Clinical Operations, providing guidance and expertise regarding GMP and GDP processes. They develop partnerships with enterprise business stakeholders to advance compliance solutions, embed preventive measures, and ensure transparency, escalation, and resolution of compliance matters.

This role reports to the Senior Director, Global Clinical Operations Compliance Lead.

Essential Functions:

1. Identify and anticipate issues impacting business goals; develop improvement and resolution methods.
2. Lead and participate in global initiatives, working groups, and project teams to ensure GMP and GDP compliance.
3. Understand end-to-end manufacture and labeling of clinical supplies, including Annex 13 and PSF.
4. Work with study teams to ensure proper root cause assessments, CAPA, and lessons learned are in place and communicated.
5. Contribute to study document design to ensure quality by design and compliance.
6. Design and implement risk management strategies for clinical studies and collaborate with stakeholders to ensure compliance with regulations and policies.
7. Maintain expertise in GMP and GDP regulations, industry best practices, and internal policies.
8. Support inspection preparations and management for health authority inspections.
9. Provide leadership to project teams and oversee work of reports, ensuring successful outcomes.
10. Manage budgets and maintain awareness of compliance project portfolios.

Supervisory Responsibilities:

May or may not manage direct/indirect reports.

Computer Skills:

Proficiency with Word, Excel, PowerPoint, Visio, Outlook, etc.

Qualifications:

• Bachelor’s Degree + 10 years in pharmaceutical/biotech drug development.
• Minimum 3+ years in GCP-related quality assurance.
• Strong ethics, judgment, organizational, and leadership skills.
• Knowledge of GMP, GDP, and regulatory environment.
• Desirable: Clinical supply chain background, familiarity with Annex 13, GMP product release processes.

Travel: May be required (10-20%).

Global Competencies include:

• Fosters teamwork, provides feedback, acts inclusively, demonstrates initiative, and more.

Salary Range: $168,600 - $228,600 annually.

BeOne is committed to fair compensation, with packages determined by skills, experience, and location. Benefits include health coverage, 401(k), stock options, and more.

We are an equal opportunity employer, valuing diversity and merit.

About Us

BeOne is a global oncology company dedicated to affordable, accessible cancer treatments, with over 11,000 colleagues worldwide. Learn more at www.beigene.com.

For Mainland China Candidates

Visit our site for opportunities in China Mainland.

Our Values

At BeOne, how we work matters as much as what we do, guided by our core values.