Global Quality Systems & Compliance Director

Merck & Co.; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Matching

Performance Bonus

Job summary

Fujifilm Biotechnologies in Holly Springs, NC, seeks a strategic Director of Quality Systems and Compliance to lead PQS, audits, documentation, and global regulatory readiness. This role partners across functions to strengthen data integrity and a proactive quality culture in a fast-paced biopharma setting.

The candidate will drive continuous improvement, oversee CAPAs, and lead end-to-end inspection readiness for regulatory and customer audits, while mentoring a high-performing team committed

Qualifications

• Bachelor's degree in Engineering or Life Science with 10+ years of related experience; OR Master's with 8+ years.
• 6+ years of people management and leadership experience.
• 2+ years leading and developing leaders (managers/supervisors).
• Experience in cGMP manufacturing operations and FDA/EMA regulated facility.
• Experience with regulatory inspections from multiple global health authorities.

Responsibilities

• Lead quality systems and compliance program across site.
• Ensure PQS alignment with GMP, GDP, and regulatory requirements.
• Own site Inspection Readiness Program and readiness metrics.
• Drive inspections, lead regulatory inspections and customer audits; draft responses.
• Ensure GxP compliance and proactive quality culture across teams.
• Develop CAPAs and remediation plans with proven effectiveness.
• Provide site quality performance data and drive management reviews.
• Identify process improvements aligning with best practices.
• Partner with clients and internal stakeholders to support QA initiatives.
• Represent site in global forums to harmonize practices.
• Mentor staff; participate in recruitment and development.

Skills

Quality leadership

Regulatory knowledge

Audits & inspections

Data integrity

GxP compliance

People management

Strategic thinking

Travel readiness

Education

Bachelor's or Master in Engineering or Life Science

Tools

TrackWise

Veeva

Job description

Fujifilm Biotechnologies in Holly Springs, NC, seeks a strategic Director of Quality Systems and Compliance to lead PQS, audits, documentation, and global regulatory readiness. This role partners across functions to strengthen data integrity and a proactive quality culture in a fast-paced biopharma setting.

The candidate will drive continuous improvement, oversee CAPAs, and lead end-to-end inspection readiness for regulatory and customer audits, while mentoring a high-performing team committed