Global Quality Systems Director

Replimune-2; Framingham (MA); On-site; USD 192,000 - 248,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune is seeking a Director of Quality Systems in Framingham, MA to lead development and implementation of quality systems ensuring compliance with ICH guidelines and global regulations.

The role reports to the Senior Director, Quality Assurance and manages document control, training, CAPA, deviation management and inspection readiness, including leadership of the international quality systems team.

Qualifications

• 10 years' experience in QA or Quality Systems in pharma.
• Experience with electronic documentation systems.
• Experience with inspection management.
• Lean/Six Sigma or Operational Excellence desirable.
• Cross-functional experience across sites/time zones.
• Strong verbal and written communication.
• Good conflict management and negotiation skills.
• Ability to work independently and in a team environment.

Responsibilities

• Oversee/Manage a compliant Quality System per ICH Q10.
• Include document management, training, change control, deviation management, CAPA.
• Quality metrics reporting and trending; inspection readiness.
• Lead quality systems staff and ensure customer service to the business.
• Coordinate with multiple sites and stakeholders to mitigate risk.

Skills

Electronic documentation systems

Verbal and written communication

Conflict management & negotiation

Independent working and collaboration

Education

Bachelor's degree

Tools

MasterControl

Job description

Replimune is seeking a Director of Quality Systems in Framingham, MA to lead development and implementation of quality systems ensuring compliance with ICH guidelines and global regulations.

The role reports to the Senior Director, Quality Assurance and manages document control, training, CAPA, deviation management and inspection readiness, including leadership of the international quality systems team.