Director of Quality, GxP Compliance & Audits

Larimar Therapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Incentive stock options

401K benefits

Flexible PTO policy

Job summary

A biotech company is seeking a Director of Quality to enhance their Quality Management System and manage GCP/GCLP/GVP compliance across clinical studies. Ideal candidates will have a Bachelor’s in life sciences and over 10 years in Quality roles, along with expertise in GCP regulations. The position includes responsibilities such as audit management, supporting regulatory inspections, and developing quality processes. Benefits include stock options and a comprehensive health plan.

Qualifications

• 10+ years in a Quality role for Clinical Operations or Pharmacovigilance.
• Experience managing GCP/GCLP/GVP quality processes.
• At least 3 years performing GCP/GCLP/GVP audits or similar.

Responsibilities

• Develop and execute risk-based audit strategy.
• Oversee external audits of GCP/GCLP/GVP vendors.
• Support inspection readiness and regulatory submissions.

Skills

Experience in Quality roles

GCP/GCLP/GVP regulations knowledge

Attention to detail

Process improvement initiative

Education

Bachelor’s degree in life sciences

Job description

A biotech company is seeking a Director of Quality to enhance their Quality Management System and manage GCP/GCLP/GVP compliance across clinical studies. Ideal candidates will have a Bachelor’s in life sciences and over 10 years in Quality roles, along with expertise in GCP regulations. The position includes responsibilities such as audit management, supporting regulatory inspections, and developing quality processes. Benefits include stock options and a comprehensive health plan.