Clinical Quality Assurance Consultant

Lead GCP and QMS compliance from anywhere in the US as our expert QA Consultant.

Proclinical is seeking a QA Consultant to support quality assurance activities within the pharmaceutical and oncology sectors. This is a remote, contract role with a focus on Good Clinical Practice (GCP) compliance and Quality Management Systems (QMS).

The successful candidate will play a key role in ensuring adherence to quality standards and regulatory requirements while collaborating with cross‑functional teams.

• Strong knowledge of GCP regulations and ISO standards.
• Proficiency in Quality Management Systems (QMS).
• Familiarity with Ideagen Q-Pulse tool is a plus.
• Excellent communication and influencing skills for engaging stakeholders.
• Strong problem‑solving, risk assessment, and CAPA management abilities.
• Experience in Quality Assurance, GCP compliance, or risk‑based auditing within the pharmaceutical or biotech industry.
• Hands‑on experience with internal audits, supplier audits, and regulatory inspections.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Degree in a relevant field such as Life Sciences, Quality Management, or Regulatory Compliance.

• Assist in establishing and maintaining the QA system in collaboration with the UK Team Lead.
• Manage compliance issues, including deviations, complaints, risk assessments, and CAPAs.
• Maintain accurate documentation of QMS activities.
• Oversee the review process for controlled documents.
• Collaborate with internal teams to drive continuous improvement of quality standards.
• Support risk‑based internal audits and manage supplier audits to ensure compliance.
• Assist with external client audits and regulatory inspections.

For questions, please contact Alex Bill at .