Associate Director/Director, Quality & Compliance
Location: UK
Job Summary
Our Associate Director, Quality and Compliance provides leadership and guidance to colleagues, ensuring high standards and timely and sustainable completion of projects. This is done by overseeing the development and updating of the Quality Management System and ongoing compliance associated with it ensuring that all legal and ethical requirements are met.
This individual also supports improvements related to internal processes and governance around new business development, client onboarding, and life cycle management of projects.
Associate Director, Quality and Compliance will work in a fast-paced consultancy environment with a team of like-minded colleagues specifically within OPEN Health’s Evidence & Access (E&A) Center of Excellence (CoE).
Level of experience and ability to effectively manage members of the team along with partnering with the Practice and Operations Leads to create efficiencies justifies a more senior role.
Essential Duties & Responsibilities
- Leading the development, implementation, and oversight of quality and compliance processes across the Evidence & Access (E&A) Center of Excellence
- Ensuring full compliance with applicable laws, regulations, and ethical standards, including those governing RWE, PCO, and human subject research
- Advising on best practices to enhance efficiency, innovation, and sustainability throughout project lifecycles
- Overseeing client and internal audits, including preparation, conduct, and resolution of findings
- Supporting governance of new business processes, including client onboarding, vendor qualification, and subcontractor assessments
- Collaborating with senior leadership to align quality efforts with operational goals and strategic initiatives
- Guiding project delivery teams through compliance considerations, issue resolution, and escalation management
- Facilitating training, mentoring, and the communication of key learnings to drive continuous improvement
- Acting as Data Privacy Champion for the E&A practice to ensure adherence to data protection regulations
- Reviewing and approving high-impact client deliverables such as protocols, ethics documentation, and final reports
- Contributing to business development by identifying quality-related risks and opportunities in new engagements
Experience, Skills, and Qualifications
- Bachelor’s degree required; advanced degree preferred
- 10+ years of relevant experience in quality and compliance within healthcare or life sciences, ideally in an Agency, CRO or Pharma environment
- Deep understanding of compliance frameworks for RWE and PCO projects, including regulations governing human subject research
- Proven experience with Quality Management Systems (QMS) development and oversight
- Strong familiarity with industry standards, including GPP, GCP, GDPR, and SOPs relevant to non-interventional research
- Knowledge of NHS structure and UK healthcare systems; global experience a plus
- Experience evaluating and supporting healthcare research methodologies and data collection
- Demonstrated leadership and team management skills within a matrixed or fast-paced environment
- Excellent critical thinking, communication, and stakeholder engagement capabilities
- High attention to detail, organization, and process rigor
- Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams)
Travel Requirements
- 5-10% potential global travel