Quality Assurance Manager

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.