Job Description
Responsibilities:
- Develop SOPs to ensure a fit-for-purpose clinical auditing and inspection management program.
- Develop dynamic, risk-based audit strategy and plan for critical sponsor processes.
- Plan, lead, conduct, document, report, and follow-up of clinical quality audits.
Qualifications:
- 10+ years of experience in clinical quality assurance and GCP compliance.
- Strong knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Clinical Laboratory Practice (GCLP) is required.
- Experience in inspection readiness and preparation.
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- Generous PTO, paid holidays and company-wide shutdowns.
About Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.