Job Description

About the Role

The Senior Director, Quality Assurance is a senior leadership role responsible for defining, implementing, and continuously improving the organization’s global Quality Management System (QMS) to ensure compliance with regulatory, client, and internal standards. This role provides strategic oversight of quality assurance across all clinical and operational activities, ensuring inspection readiness, audit excellence, and a proactive quality culture aligned to business growth objectives.

The position operates as a key member of the leadership team, partnering cross-functionally to enable compliant delivery, client confidence, and sustainable business performance.

Responsibilities

Quality Strategy & Governance

• Establish and lead the global QA strategy aligned to organizational growth, regulatory expectations, and client requirements
• Own and maintain the Quality Management System (QMS), ensuring scalability across geographies and service lines

Audit & Inspection Leadership

• Lead the global audit program across investigator sites, vendors, systems, and internal processes

• Ensure continuous inspection readiness for regulatory authorities and client audits

Regulatory Compliance & Risk Management

• Ensure compliance with global GxP standards and applicable regulatory requirements
• Monitor regulatory landscape and proactively adapt QA practices

Operational Excellence & Continuous Improvement

• Identify and implement process improvements to enhance delivery quality, efficiency, and scalability
• Leverage data and analytics to identify quality trends and systemic improvement opportunities

Client & Commercial Engagement

• Partner with Business Development and Delivery teams to support client proposals and due diligence activities
• Provide QA leadership in client engagements, audits, and escalations

Leadership & Capability Building

• Build, lead and develop a high-performing global QA team
• Ensure capability development, succession planning, and workforce scalability

Financial & Resource Management

• Own QA budget and resource allocation to ensure efficient and scalable delivery

Experience and Qualifications

• Degree in Life Sciences, Pharmacy, or related discipline
• 15+ years’ experience within CRO / pharmaceutical / clinical research environments
• Extensive experience in QA leadership roles within regulated environments
• Deep working knowledge of global GxP, ICH-GCP, and regulatory frameworks

Preferred

• Advanced degree (MSc, PhD) or relevant QA certification
• Experience leading global QA functions across multiple regions
• Demonstrated regulatory inspection leadership experience (FDA, EMA, etc.)

Salary Band – Senior Director Quality Assurance $200,000 to $270,000 USD – Salary offered will be based on candidates experience level.

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.