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.
About UsNovotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Skills Required
- 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
What We Do
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.
