Director, Global Clinical Supply Compliance

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

Job summary

A leading company in the biotech industry is seeking a Director of Global Clinical Supply Compliance. This role requires a candidate with extensive experience in drug development and compliance, emphasizing ethics and project management. You will lead global compliance initiatives and mentor teams to ensure compliance with industry standards, all while managing project budgets. If you have a strong background in QA and supply chain and are motivated to contribute to excellence in patient care, this opportunity is for you.

Benefits

Comprehensive health benefits

Retirement options

Stock options

Qualifications

• At least 10 years in pharmaceutical/biotech drug development.
• Minimum of 3+ years in GCP-related quality assurance roles.
• Knowledge of GMP, GDP, and evolving industry standards.

Responsibilities

• Lead compliance initiatives, ensuring adherence to GMP and GDP.
• Mentor and develop project teams, overseeing budgets and timelines.
• Collaborate with study teams to execute root cause assessments.

Skills

Excellent interpersonal skills

Strong ethics

Stakeholder management

Organizational skills

Communication skills

Education

Bachelor's Degree in pharmaceutical/biotech

Job description

Director, Global Clinical Supply Compliance

Apply locations: Remote (US) | Time type: Full time | Posted on: Posted 10 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 needs of the business. They drive compliance activities within Global Clinical Operations, providing guidance on GMP and GDP processes, developing partnerships to advance compliance solutions, and ensuring transparency and resolution of compliance matters. This role reports to the Senior Director of Global Clinical Operations Compliance.

Essential Functions:

1. Identify and anticipate potential issues impacting business goals; develop improvement and resolution strategies.
2. Lead and participate in global initiatives, working groups, and project teams to ensure compliance with GMP, GDP, laws, and regulations.
3. Understand end-to-end manufacture and labeling of clinical supplies, including Annex 13 and PSF.
4. Collaborate with study teams to ensure proper root cause assessments, corrective actions, and lessons learned are implemented and communicated.
5. Contribute to study document design to ensure quality by design and preventative compliance.
6. Design and implement risk management strategies for clinical studies and drug development activities, providing expertise on systems, processes, and regulations.
7. Maintain expertise in GMP and GDP guidelines, industry best practices, and internal policies to promote quality and compliance.
8. Support inspection preparations and management for health authority inspections.
9. Provide leadership to project teams and oversee work of reports, ensuring timely and within-budget results.
10. Mentor and develop direct and indirect reports, conducting regular communication and performance reviews.
11. Manage project budgets and maintain awareness of the GCO Compliance project portfolio.

Qualifications:

• Bachelor’s Degree with at least 10 years in pharmaceutical/biotech drug development, preferably in QA, Supply Chain, Manufacturing, or Regulatory Compliance.
• Minimum of 3+ years in GCP-related quality assurance roles.
• Strong ethics, judgment, and discretion.
• Experience in managing high-level initiatives, stakeholder management, and influencing change.
• Excellent interpersonal, organizational, and communication skills.
• Knowledge of evolving laws, GMP, GDP, and industry standards.
• Desirable: Clinical supply chain background, familiarity with Annex 13, product release processes, and manufacturing/labelling processes.

Additional Information:

Travel may be required (10-20%).

Our values include Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, supported by twelve global competencies such as teamwork, feedback, inclusivity, and results orientation.

Salary Range: $168,600 - $228,600 annually. Compensation is determined by skills, experience, and location. BeOne offers comprehensive benefits including health, retirement, and stock options.

BeOne is an equal opportunity employer, committed to diversity and inclusion.