Senior Manager, GCP Quality Assurance

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Oversee GCP/Clinical Quality Assurance functions

• Guarantee the quality and compliance of clinical trials sponsored by Madrigal

• Create, implement, and/or sustain clinical quality systems and procedures

• Foster an organization-wide commitment to a quality culture in line with ICH guidelines

• Collaborate with external clinical trial vendors

• Conduct or oversee internal and external audits

• Lead review processes, manage documentation, and monitor Observations/Findings

• Evaluate key documents related to clinical programs or studies

⛳️ Requirements

• At least 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO sectors

• A minimum of 3-5 years of experience in a clinical operations position at a CRO or Sponsor

• Experience in preparing for inspections and/or supporting inspections by health authorities or regulatory agencies

• Proven knowledge of GCP standards

• Bachelor's degree in a scientific or relevant field, or equivalent work experience

🏝️ Benefits

• Flexible paid time off

• Medical insurance

• Dental insurance

• Vision insurance

• Life/disability insurance

• 401(k) options (traditional, Roth, employer match)

• Supplemental life insurance

• Legal services

• Mental health support through the Employee Assistance Program