Associate Director/Senior Manager, Clinical QA

Driving Quality Excellence in Global Clinical Development

Join a global quality function to provide strategic leadership across research, clinical, and safety-related processes. This role focuses on ensuring the effective application of quality standards, regulatory requirements, and risk-based methodologies within a regulated environment. You will work closely with cross-functional teams and external partners to strengthen quality performance, support audit and inspection readiness, and enable successful programme delivery.

Core Responsibilities

• Develop and maintain quality oversight plans for assigned development programs, supporting key objectives throughout product development and post-approval activities.
• Assess and mitigate quality and compliance risks across operational processes, technologies, third-party partners, and global activities using risk-based methodologies.
• Promote adherence to applicable quality regulations, industry standards, and company policies while driving efficient and streamlined ways of working.
• Lead quality oversight activities to support participant protection, reliable outcomes, and regulatory compliance across development programs.
• Coordinate inspection preparation activities and documentation reviews with cross-functional experts and operational stakeholders.
• Proactively identify emerging quality concerns, communicate risks to stakeholders, and implement appropriate mitigation strategies.
• Manage pre-inspection documentation quality reviews in collaboration with functional SMEs and global process owners.
• Conduct analytics and qualitative assessments to identify trends and monitor quality deliverables from vendors and partners.
• Support ongoing audit and inspection preparedness while safeguarding the quality and reliability of information submitted to regulatory authorities.
• Participate in regulatory inspections and internal reviews, helping coordinate responses, action plans, and stakeholder communications.
• Evaluate changes in regulatory expectations and industry standards, providing guidance on their impact to business processes, quality systems, and supplier relationships.
• Act as a trusted quality advisor, supporting teams in resolving complex compliance challenges and strengthening quality practices.
• Present quality insights, recommendations, and project updates to leadership teams and cross-functional stakeholders.

Key Skills and Requirements

• Degree qualification in a life sciences, healthcare, pharmaceutical, or related discipline.
• Significant experience within the pharmaceutical, biotechnology, healthcare, or other regulated industries.
• Demonstrated ability to apply regulatory requirements and quality standards to practical business and development activities.
• Experience supporting quality oversight activities within regulated environments, including auditing, inspection support, compliance management, or regulated product development.
• Proven capability to build effective partnerships across cross-functional teams and influence successful project outcomes.
• Experience working within complex international organisations, providing guidance and influencing key quality and compliance decisions.
• Strong judgement in assessing priorities, managing risks, and focusing resources on areas of greatest impact.
• Demonstrated commitment to maintaining high standards of quality, governance, and regulatory compliance.
• Ability to interpret information from multiple sources, identify trends, and provide clear, actionable recommendations.
• Confident presenter with the ability to communicate complex quality and compliance topics to a variety of audiences.
• Excellent written and verbal communication skills in English; additional European languages would be advantageous.
• Right to work in the specified location or hold an EU passport.