Global Labeling Excellence Lead - Process & Compliance

Biopharma Careers; Billerica (MA); On-site; USD 128,000 - 192,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Perquisites

Job summary

Biopharma Careers is seeking a Global Labeling Excellence Lead to advance operational excellence across global labeling activities within Regulatory Quality Safety. You will partner with process owners to implement compliant, scalable labeling processes and apply change-management methodologies to improve documentation, tracking, and overall quality.

The role emphasizes cross-functional collaboration, project planning, and oversight of labeling commitments to support regulatory expectations and

Qualifications

• Bachelor’s degree in a science or health-related discipline; advanced degree strongly preferred.
• Minimum of 5 years of pharmaceutical industry or related experience.
• Strong project management skills with stakeholder management across global, matrix environments.
• Operational excellence and continuous improvement mindset; cross-functional initiative experience.
• Ability to manage multiple priorities, meet deadlines, and maintain high-quality documentation.
• Digital tools, analytics, automation, or AI-enabled solutions experience encouraged.

Responsibilities

• Support documentation development and maintenance for global labeling processes.
• Coordinate labeling document updates and stakeholder inputs across global/regional teams.
• Develop global labeling project plans, submission timelines, and health authority tracking.
• Establish a comprehensive global labeling commitment tracker for timely follow-up.
• Monitor labeling implementations, track deviations, and ensure on-time submissions.
• Partner with RQS stakeholders on quality documentation and related deliverables.
• Identify and implement process improvements and new technologies to boost efficiency.

Skills

Project management

Stakeholder engagement

Cross-functional collaboration

Digital fluency

Analytical mindset

Education

Bachelor's degree in science or health-related discipline

Advanced degree (PhD/MD/MS/PharmD) preferred

Job description

Biopharma Careers is seeking a Global Labeling Excellence Lead to advance operational excellence across global labeling activities within Regulatory Quality Safety. You will partner with process owners to implement compliant, scalable labeling processes and apply change-management methodologies to improve documentation, tracking, and overall quality.

The role emphasizes cross-functional collaboration, project planning, and oversight of labeling commitments to support regulatory expectations and