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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.
Job Responsibility:
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
Requirements:
Strong knowledge of GCP regulations and ISO standards
Proficiency in Quality Management Systems (QMS)
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