GCP Quality Assurance Manager

About the role

This remote consulting position provides expert clinical quality oversight across a diverse clinical development pipeline, ensuring robust Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance. The role supports clinical trials from study start-up through late-stage development and regulatory submissions, with a strong focus on inspection readiness, audit activities, and continuous improvement of quality systems. The consultant will work closely with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external vendors in a fast-paced biotech environment, influencing key decisions that impact global clinical programs.

Responsibilities

• Lead quality oversight activities across clinical development programs to ensure compliance with internal procedures and global regulations.
• Perform internal, external, and vendor audits, including planning, execution, reporting, and follow-up of audit findings.
• Evaluate suppliers and CRO partners for GxP compliance through structured supplier audits and assessments.
• Support GCP-regulated studies from start-up through submission by conducting GCP audits and quality reviews.
• Provide quality oversight of clinical trial processes, study documentation, and quality records to maintain high compliance standards.
• Support GCP and GVP quality activities in collaboration with Clinical Operations and Pharmacovigilance teams.
• Collaborate with Safety/PV teams on GVP-related quality activities and oversight of safety processes and associated quality systems.
• Prepare teams, documentation, and systems for health authority inspections, including inspection readiness initiatives.
• Support inspection management activities involving FDA, EMA, and MHRA, including coordination and response to regulatory queries.
• Manage deviations, CAPAs, quality events, and root cause investigations, ensuring timely and effective resolution.
• Investigate quality issues, drive corrective and preventive actions, and ensure effective closure and documentation.
• Maintain compliance with global regulations and internal Quality Management System (QMS) requirements.
• Own and improve quality management processes, including risk assessments and continuous improvement initiatives.
• Support SOP development, process improvements, and risk management activities across global clinical trials.
• Partner cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and QA leadership to resolve quality issues.
• Contribute to continuous improvement initiatives that enhance inspection readiness, quality systems, and clinical compliance.
• Support activities related to oncology and immunotherapy clinical programs, including regulatory submissions and data quality oversight.

Requirements

• Minimum of 5+ years of Clinical Quality Assurance (QA) experience.
• Strong hands-on experience with Good Clinical Practice (GCP) in biotech or pharmaceutical environments.
• Proven experience supporting clinical trials across different phases of development.
• Exposure to Pharmacovigilance and Good Pharmacovigilance Practice (GVP) quality activities.
• Demonstrated audit experience, including internal, external, and vendor audits.
• Experience with regulatory inspection readiness and health authority inspections.
• Direct experience interacting with FDA, EMA, and/or MHRA on inspection or compliance matters.
• Strong stakeholder management skills with the ability to collaborate effectively with cross-functional teams.
• Excellent communication skills, both written and verbal, for engaging global stakeholders.
• Bachelor's degree or equivalent experience in a relevant scientific or healthcare discipline.
• Proficiency in managing CAPAs, deviations, quality events, and root cause analysis within a QMS framework.

Additional Qualifications

• Experience working in a fast-paced biotech setting, particularly in oncology and immunotherapy programs.
• Familiarity with global clinical trials and associated regulatory submission activities.
• Knowledge of Quality Management Systems (QMS) and risk management processes.
• Experience with inspection readiness planning and execution for global regulatory authorities.
• Comfort working with electronic quality and clinical systems such as Veeva or similar platforms.
• Ability to lead cross-functional quality initiatives and influence continuous improvement across clinical programs.
• Strong analytical and problem-solving skills, particularly in the context of CAPA and root cause analysis.
• Ability to work independently in a remote consulting capacity while maintaining strong collaboration with US and UK stakeholders.

Work Environment

This is a remote consulting position within a highly cross-functional and collaborative biotech environment. The role operates in a fast-paced setting with significant interaction with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and QA leadership. There is a preference for candidates working on Eastern Standard Time to facilitate effective collaboration with UK-based teams and global stakeholders. The position involves supporting global clinical trials, oncology and immunotherapy programs, and regulatory submission activities. Travel may be required up to approximately 30% of the time to conduct audits, attend inspections, and participate in key quality oversight meetings.

Pay

The pay range for this position is $60.00 - $80.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include the following:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)