Interim GCP Quality Assurance Manager

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

Job summary

A leading company in life sciences is seeking an Interim GCP Quality Assurance Manager to provide immediate leadership in clinical quality management. This role includes overseeing GCP compliance and quality systems across clinical trials. The position is remote and offers a competitive pay range of $100-$120 per hour, with a potential for full-time conversion.

Qualifications

• Deep experience in clinical quality and GCP compliance.
• Strong understanding of FDA, EMA, and ICH GCP regulations.

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.

Skills

Leadership

Communication

Collaboration

Education

Bachelor’s degree in life sciences

Advanced degree

Job description

This range is provided by Umbrex. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100.00/hr - $120.00/hr

Direct message the job poster from Umbrex

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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