USA - Quality Compliance Specialist

Mindlance; Cambridge (MA); Hybrid; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Quality Compliance Lead to oversee supplier audits and ensure adherence to GCP/GVP standards. This hybrid role, requiring on-site presence two days a week, offers an exciting opportunity to apply your expertise in compliance and project management within a dynamic environment. You will be responsible for conducting audits, managing clinical trial operations, and ensuring the highest quality standards. If you have a strong background in compliance and a passion for clinical quality, this position is perfect for you.

Qualifications

• Strong background in compliance and supplier audits.
• Expertise in GCP/GVP inspections and deviation management.

Responsibilities

• Conduct supplier audits and ensure compliance with GCP/GVP standards.
• Manage projects and meet deliverables effectively.

Skills

Compliance background in supplier audits

Project management skills

Knowledge of GCP/GVP inspections

Deviation management

Experience in Phase I clinical trials

Job description

Job Description: Clinical Quality Compliance Lead

Suppliers must submit answers to pre-screening questions during the submission process:

1. Describe your compliance background, specifically in supplier audits, GCP/GVP inspections, and deviation management.
2. Describe your project management skills and how they meet deliverables.
3. Estimate the number of GCP supplier audits conducted within the last 5 years.
4. Estimate the number of GCLP supplier audits (including central labs and clinical specialty labs) conducted within the last 5 years.
5. Estimate the number of GVP supplier audits (including types, license partners, MRPSP, etc.) conducted within the last 5 years.
6. Describe your knowledge of computerized systems assessment for GCP/GVP audits.
7. Describe your knowledge level of Phase I clinical trials and your audit experience in this area.
8. Describe your strongest and weakest areas of clinical trial management/operations.

Compensation: Max bill rate is *** per hour.

Position: Actual job title: Clinical Quality Compliance Lead

This role combines responsibilities from the two attached job descriptions.

Location: 500 Kendall Street, Cambridge, MA 02142

Hybrid role: 2 days per week on-site.

Start Date: January, for approximately 1 to 1.5 years.

EEO Statement:

Mindlance is an Equal Opportunity Employer and does not discriminate based on minority, gender, disability, religion, LGBTQI+, age, or veteran status.