The Bioanalytical & Central Laboratory QA Manager is responsible for overseeing the Quality Assurance (QA) function across both bioanalytical laboratory operations and the CAP-accredited central laboratory.
This role ensures compliance with GLP, GCLP, CAP requirements, and ICH guidelines, while maintaining data integrity, inspection readiness, and continuous quality improvement.
Key Responsibilities
- Maintain and improve Quality Management System (QMS)
- Ensure GLP, GCLP, CAP and ICH GCP compliance and lead inspections
- Lead audits and regulatory inspections
- Oversee deviation, investigation, and CAPA processes
- Ensure data integrity and computerized system compliance
- Provide QA oversight for Lab studies
- Lead quality related training and promote quality culture
- Drive continuous improvement and KPI monitoring
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Medical Technology, Pharmacy, Chemistry, or a related discipline
- Minimum 5 years of experience in a regulated laboratory environment, with substantial Quality Assurance responsibilities in bioanalytical and/or clinical laboratory settings
- At least 3 years of leadership experience in QA or laboratory operations, with demonstrated ability to manage teams and cross-functional stakeholders
- Proven experience working in compliance with Good Laboratory Practice (GLP) and/or College of American Pathologists (CAP)-accredited laboratories
- Strong hands-on experience in regulatory inspections, sponsor audits, and CAP accreditation processes
- Solid understanding of bioanalytical laboratory operations (e.g., ligand-binding assays, immunogenicity, or LC-MS/MS) and/or clinical central lab workflows
- Familiarity with Quality Management Systems (QMS), including deviation, CAPA, change control, and risk management
- Experience with data integrity principles (ALCOA+) and computerized systems (e.g., LIMS, audit trail review, CSV) is highly preferred
- Excellent communication, problem-solving, and organizational skills, with the ability to operate in a fast-paced, regulated environment
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.
Novotech 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
- Bachelor's or Master's degree in Life Sciences, Medical Technology, Pharmacy, Chemistry, or a related discipline
- Minimum 5 years of experience in a regulated laboratory environment
- At least 3 years of leadership experience in QA or laboratory operations
- Proven experience working in compliance with Good Laboratory Practice (GLP) and/or College of American Pathologists (CAP)-accredited laboratories
- Strong hands-on experience in regulatory inspections and sponsor audits
- Solid understanding of bioanalytical laboratory operations
- Familiarity with Quality Management Systems (QMS)
- Experience with data integrity principles (ALCOA+) and computerized systems
- Excellent communication and organizational skills
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.
