Clinical QA Senior Project Manager (GCP)

Location: Remote, Reading, United Kingdom

Company

hirify.global Strategic Solutions is a sponsor-dedicated clinical research organization providing global clinical development and functional service partnership support.

What you will do

• Lead the development, revision, implementation, and retirement of SOPs, work instructions, controlled documents, and guidance materials.
• Drive cross-functional process improvement initiatives focused on efficiency, compliance, and operational excellence.
• Partner with Quality Assurance and Clinical Operations to support inspection readiness and regulatory inspections.
• Lead quality event investigations, root cause analyses, CAPA development, and effectiveness checks.
• Manage complex projects, align global stakeholders, monitor performance, and report progress to senior leadership.
• Develop training and onboarding initiatives while mentoring colleagues as a subject matter expert in procedural excellence and clinical quality.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Healthcare, or a related field.
• At least 7 years of experience in the biopharmaceutical, biotechnology, CRO, or clinical research industry.
• Strong background in clinical operations, quality, compliance, or process excellence.
• Deep understanding of GCP, ICH guidelines, and global clinical trial conduct.
• Experience leading cross-functional projects, improving processes, and managing controlled documents.
• Strong project management, communication, facilitation, stakeholder management, and written and verbal English skills.

Nice to have

• Sponsor-side clinical research experience.
• Inspection readiness, audit support, or regulatory inspection experience.
• Quality systems, CAPA management, and deviation investigation experience.
• Experience with Veeva QMS, learning management platforms, or clinical development systems.

Culture & Benefits

• Remote working in a global sponsor-dedicated environment.
• Annual leave and country-specific health insurance options.
• Retirement planning offerings and life assurance.
• Global Employee Assistance Programme with 24-hour access to wellbeing professionals.
• Optional benefits may include childcare vouchers, bike purchase schemes, gym memberships, travel passes, and health assessments.
• Inclusive workplace focused on diversity, belonging, accessibility, and equal opportunity.