Interim GCP Quality Assurance Manager

Umbrex; San Francisco (CA); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading life sciences company is urgently seeking an Interim GCP Quality Assurance Manager to provide immediate leadership in clinical quality management. This role involves oversight of GCP compliance and quality systems across clinical trials, with the potential for full-time conversion. Ideal candidates will have director-level experience and deep expertise in maintaining quality standards in a fast-paced regulatory environment.

Qualifications

• Deep experience in clinical quality and GCP compliance.
• Strong understanding of FDA, EMA, and ICH GCP regulations.
• Proven track record in preparing for and managing health authority inspections.

Responsibilities

• Lead GCP quality management activities across clinical development programs.
• Develop, implement, and maintain clinical quality systems and SOPs.
• Serve as the primary point of contact for regulatory inspections and responses.

Skills

Clinical quality

GCP compliance

Leadership

Cross-functional collaboration

Communication

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job description

Our client, a life sciences company, is urgently seeking an Interim GCP Quality Assurance Manager following the departure of a key team member. This is a high-impact opportunity for a seasoned professional to provide immediate leadership in clinical quality management.

This role will provide oversight of GCP compliance and quality systems across clinical trials and development programs. The selected candidate will bring director-level experience and deep expertise in maintaining and enhancing quality standards in a fast-paced regulatory environment.

This project has the opportunity to convert to a full-time role.

Key Responsibilities:

• Lead GCP quality management activities across clinical development programs
• Develop, implement, and maintain clinical quality systems and SOPs
• Provide strategic guidance on GCP compliance and inspection readiness
• Oversee internal audits and manage external vendor/CRO audit processes
• Collaborate cross-functionally with clinical, regulatory, and QA teams
• Identify and mitigate compliance risks; lead CAPA processes when necessary
• Serve as the primary point of contact for regulatory inspections and responses

Qualifications:

• Deep experience in clinical quality and GCP compliance
• Strong understanding of FDA, EMA, and ICH GCP regulations
• Experience developing and managing clinical quality systems in a life sciences or pharmaceutical company
• Proven track record in preparing for and managing health authority inspections
• Excellent communication, leadership, and cross-functional collaboration skills
• Bachelor’s degree in life sciences or related field required; advanced degree preferred

Start: ASAP

Duration: 3 months with possible extension

Time commitment: 5 days per week

Location: Remote

Expected range: $100-$120 per hour

Project ID#: 5634

*This is a 1099 contract role that does not offer benefits