Senior Clinical QA Project Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee and manage projects, ensuring effective execution and achievement of project goals.

• Handle daily project and program management tasks.

• Spearhead the creation, revision, implementation, and retirement of controlled documents, standard operating procedures (SOPs), work instructions, and guidance materials.

• Propel cross-functional process enhancement initiatives.

• Collaborate with Quality Assurance and Clinical Operations teams to facilitate inspection readiness and support for regulatory inspection activities.

• Direct investigations into quality events, conduct root cause analyses, develop corrective and preventive actions (CAPA), and check for effectiveness.

• Manage intricate projects involving multiple stakeholders, ensuring timely achievement of business goals.

• Promote stakeholder alignment and influence process modifications across global teams.

• Create and implement training, onboarding, and learning initiatives.

• Track process performance, identify areas for improvement, and report progress to senior leadership.

• Guide colleagues and act as a subject matter expert in procedural excellence and clinical quality.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Healthcare, or a related discipline.

• Over 7 years of experience in the biopharmaceutical, biotechnology, CRO, or clinical research sectors.

• Strong background in clinical operations, quality, compliance, or process excellence.

• In-depth knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and global clinical trial execution.

• Proven experience in leading cross-functional projects and process improvement efforts.

• Experience in authoring and managing SOPs, procedures, work instructions, or other controlled documents.

• Exceptional project management, communication, facilitation, and stakeholder management abilities.

• Proficient written and verbal communication skills in English.

• Clinical research experience from the sponsor-side is preferred.

• Experience in inspection readiness, audit support, or regulatory inspections is preferred.

• Familiarity with quality systems, CAPA management, and deviation investigations is preferred.

• Experience with Veeva Quality Management System (QMS), Learning Management Systems (LMS), or clinical development systems is preferred.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.