Quality Assurance Manager

Morgan Prestwich - Life Science & Healthcare Executive Search; California (MO); Remote; USD 85,000 - 150,000; Full time

Job summary

A leading firm in clinical research seeks a Quality Assurance Manager to uphold global quality standards and ensure compliance with Good Clinical Practice (GCP) guidelines. This is a full-time remote position ideal for candidates with extensive GCP experience and a passion for quality management.

Qualifications

• 5 years’ experience in quality assurance with focus on GCP.
• In-depth knowledge of GCP and global regulatory frameworks.
• Strong organizational skills for managing multiple tasks.

Responsibilities

• Oversee and maintain QMS documentation aligning with GCP.
• Organize internal and external audits prioritizing GCP compliance.
• Support teams during regulatory inspections and provide training.

Skills

GCP Compliance

Quality Management

Auditing

Communication

Education

Bachelor’s degree in life sciences

Job description

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Global Client Partner- Interims, Medical, Clinical, Regulatory and Quality at Morgan Prestwich

Job Title: Quality Assurance Manager

Location: United States

Type: Full-time, 6-12+ month Contract, Remote (must be US based)

Role Overview

We are partnering with an innovative company in the clinical research field to recruit a dedicated Quality Assurance Manager. This vital position focuses on upholding global quality standards, ensuring robust quality systems, and achieving successful audit and inspection outcomes. The role places a strong emphasis on Good Clinical Practice (GCP) compliance, requiring candidates with extensive GCP experience, while other GxP areas are less critical.

Position Summary

As the Quality Assurance Manager, you will be instrumental in managing the Quality Management System (QMS), supervising audit processes, and supporting quality training efforts. The role involves close collaboration with internal teams and external partners to ensure compliance with GCP and regulatory standards.

Key Duties

Quality System Management

• Oversee and maintain QMS documentation, including policies, SOPs, and templates, ensuring alignment with GCP and international regulations.
• Monitor deviations, implement corrective measures, and maintain accurate quality records.

Audit Planning and Execution

• Organize and track internal and external audits, prioritizing GCP compliance, and ensure prompt resolution of findings.
• Review audit reports, manage corrective and preventive actions (CAPAs), and uphold documentation standards.

Inspection Preparation and Compliance

• Support teams in preparing for regulatory inspections, offering training and on-site assistance, with a focus on GCP requirements.
• Respond to inspection observations with timely and effective solutions.

Training and Guidance

• Provide introductory training on quality and regulatory topics, emphasizing GCP principles.
• Offer expert advice to project teams to promote a culture of compliance.

Candidate Requirements

• Bachelor’s degree in life sciences or a related discipline.
• Minimum of 5 years’ experience in quality assurance within the pharmaceutical or clinical research industry, with a primary focus on GCP.
• In-depth knowledge of GCP and global regulatory frameworks.
• Strong organizational abilities to handle multiple tasks effectively.
• Exceptional communication skills, with a talent for collaboration and influence across teams.

This position is ideal for professionals with deep GCP expertise and a passion for maintaining compliance in clinical research.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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