Are you a Clinical Quality leader who thrives on driving compliance, inspection readiness, and quality excellence across global development programmes?
Proclinical is seeking an Associate Director/Senior Manager, Clinical QA to join a global quality function supporting development and lifecycle management activities within a regulated environment. In this role, you will provide quality leadership across research, clinical, and safety-related processes, ensuring the effective application of quality standards, regulatory requirements, and risk-based methodologies. 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.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
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.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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